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

FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE

K Number: K933770 · Decision Mar 23, 1994
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
8
Review Days
237

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Basic Information

Device Name
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
K Number
K933770
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
874.4420
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Mahe-Medizintechnik
Date Received
July 29, 1993
Decision Date
March 23, 1994
Product Code
LRC
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
EN
Third Party
N

Classifications

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

Product Code Device Name
LRC Instrument, Ent Manual Surgical

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Other Clearances by Mahe-Medizintechnik

K Number Device Name
K942821 MAHE INSTRUMENTS
K942819 TROCAR WITH SHIELD
K933768 COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
K933767 FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
K935442 MAHE INSTRUMENTS
K933772 PUNCH SURGICAL
K925624 MICROSURGICAL INSTRUMENTS