NEUROTOLOGY DRAPE, MODEL TBD


definition

Device Classification Name

drape, surgical

510(k) Number K002702
Device Name NEUROTOLOGY DRAPE, MODEL TBD
Original Applicant
GYRUS ENT L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Original Contact greg sredin
Regulation Number 878.4370
Classification Product Code
KKX  
Date Received 08/30/2000
Decision Date 10/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No