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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
510(k) Number K781420
Device Name SPECIALTY SPONGES
Applicant
Ipco Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ipco Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
EFQ  
Date Received08/15/1978
Decision Date 10/03/1978
Decision Substantially Equivalent (SESE)
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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