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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853286
Device Name STAPLE REMOVER
Applicant
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Applicant Contact AMIR PORAT
Correspondent
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Correspondent Contact AMIR PORAT
Date Received08/05/1985
Decision Date 08/21/1985
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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