SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L


Device Classification Name

syringe, piston

510(k) Number K081524
Device Name SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
Applicant
SPECTRA MEDICAL DEVICES, INC.
4501 greendale drive
williamsburg, 
VA 
23188

Applicant Contact scott henderson
Correspondent
SPECTRA MEDICAL DEVICES, INC.
4501 greendale drive
williamsburg, 
VA 
23188

Correspodent Contact scott henderson
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 06/02/2008
Decision Date 07/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No