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

STEPHENS DISPOSABLE FORCEPS

K Number: K022835 · Decision Nov 1, 2002
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
5
Review Days
66

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Basic Information

Device Name
STEPHENS DISPOSABLE FORCEPS
K Number
K022835
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.4350
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Stephens Instruments
Date Received
August 27, 2002
Decision Date
November 1, 2002
Product Code
HNR
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

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

Product Code Device Name
HNR Forceps, Ophthalmic

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Other Clearances by Stephens Instruments

K Number Device Name
K022840 STEPHENS DISPOSABLE SCISSORS
K022843 GAYHEART CORNEAL EXCISION DEVICE
K022836 STEPHENS DISPOSABLE SPECULUM
K022842 STEPHENS DISPOSABLE HOOKS