FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CLEAN SCRAPE

K Number: K003773 · Decision Feb 2, 2001
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
2
Review Days
58

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Basic Information

Device Name
CLEAN SCRAPE
K Number
K003773
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Webb Research Ii, Inc.
Date Received
December 6, 2000
Decision Date
February 2, 2001
Product Code
GEI
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
GEI Electrosurgical, Cutting & Coagulation & Accessories

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Other Clearances by Webb Research Ii, Inc.

K Number Device Name
K934755 FAST FIND GRIND