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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K946024
Device Name 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS
Applicant
3M Healthcare
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Applicant Contact MARVIN L HART
Correspondent
3M Healthcare
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Correspondent Contact MARVIN L HART
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/09/1994
Decision Date 02/08/1995
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
Predetermined Change
Control Plan Authorized		 No
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