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

VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS

K Number: K042604 · Decision Oct 22, 2004
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
27
Review Days
28

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Basic Information

Device Name
VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
K Number
K042604
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Valley Forge Scientific Corp.
Date Received
September 24, 2004
Decision Date
October 22, 2004
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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K971986 VALLEY FORGE BIPOLAR LOOP
K964143 MINI-SYMM BIPOLAR COAGULATOR
K955764 VALLEY FORGE BIPLOAR LOOP
K955346 VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM
K951985 PRECISION BIPOLAR COAGULATOR
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