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FDA 510(k) Application Details - K003015
Device Classification Name
Suture, Absorbable, Synthetic
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510(K) Number
K003015
Device Name
Suture, Absorbable, Synthetic
Applicant
SURGICAL SPECIALTIES CORP.
100 DENNIS DR.
READING, PA 19606 US
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Contact
VIKKI M HOFFMAN
Other 510(k) Applications for this Contact
Regulation Number
878.4830
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Classification Product Code
GAN
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More FDA Info for this Product Code
Date Received
09/27/2000
Decision Date
12/15/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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