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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K940436
Device Name SPONGE, LAPAROTOMY, VARIOUS SIZE
Applicant
Shawnee Products, Inc.
1201 Holly Ln., Bldg. #3
Tecumseh,  OK  74873
Applicant Contact EARL L LITTLE
Correspondent
Shawnee Products, Inc.
1201 Holly Ln., Bldg. #3
Tecumseh,  OK  74873
Correspondent Contact EARL L LITTLE
Regulation Number878.4450
Classification Product Code
GDY  
Date Received01/31/1994
Decision Date 07/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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