FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

GAUZE SPONGES

K Number: K924650 · Decision Jan 11, 1993
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
2
Review Days
118

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Basic Information

Device Name
GAUZE SPONGES
K Number
K924650
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4014
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Dav-Mar Medical Products, Inc.
Date Received
September 15, 1992
Decision Date
January 11, 1993
Product Code
NAB
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
NAB Gauze / Sponge,Nonresorbable For External Use

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (NAB), ordered by most recent decision date.

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Other Clearances by Dav-Mar Medical Products, Inc.

K Number Device Name
K936216 STERILE GAUZE SPONGES