SELF SEAL STERILIZATION POUCH


Device Classification Name

wrap, sterilization

510(k) Number K023025
Device Name SELF SEAL STERILIZATION POUCH
Original Applicant
GRANTON MEDICAL LTD.
po box 4341
crofton, 
MD 
21114

Original Contact e. j. smith
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 09/11/2002
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No