PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K992091
Device Name PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
Applicant
BIO-PLEXUS, INC.
129 reservoir rd.
vernon, 
CT 
06066 -5705

Applicant Contact paul a tenthorey
Correspondent
BIO-PLEXUS, INC.
129 reservoir rd.
vernon, 
CT 
06066 -5705

Correspodent Contact paul a tenthorey
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 06/21/1999
Decision Date 09/09/1999
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