FDA 510(k) Application Details - K961168

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K961168
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
5500 AVION PARK DR.
HIGHLAND HEIGHTS, OH 44143 US
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Contact ELAINE K KEELER
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Regulation Number 878.5010

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Classification Product Code GAW
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Date Received 03/25/1996
Decision Date 05/16/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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