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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K870900
Device Name THE GRIPPER SEAL(TM)
Applicant
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact EDWARD NUMAINVILLE
Correspondent
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact EDWARD NUMAINVILLE
Regulation Number880.5240
Classification Product Code
KGX  
Date Received03/05/1987
Decision Date 03/31/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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