S.C.O.R.E.S. UNIT


Device Classification Name

sterilization wrap containers, trays, cassettes & other accessories

510(k) Number K110898
Device Name S.C.O.R.E.S. UNIT
Applicant
AMMED SURGICAL EQUIPMENT, LLC
8708 capehart cove
austin, 
TX 
78733

Applicant Contact david c furr
Correspondent
AMMED SURGICAL EQUIPMENT, LLC
8708 capehart cove
austin, 
TX 
78733

Correspodent Contact david c furr
Regulation Number 880.6850
Classification Product Code
KCT  
Date Received 03/30/2011
Decision Date 07/26/2012
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