Atlas FDA

SOPHER AND BIERER OVUM FORCEPS

FDA 510(k) clearance K926540 · decided 1994-02-25

Clearance details

K-number
K926540
Device name
SOPHER AND BIERER OVUM FORCEPS
Applicant
Thomasville Medical Assoc.
Decision
Substantially Equivalent
Date received
1992-12-30
Decision date
1994-02-25
Days to decision
422 days
Clearance type
Traditional
Product code
HLZ
Device class
2
Regulation number
886.1220
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Alpharetta, GA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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TOMEY DTL ELECTRODE (K961805)Tomey Corporation USA1997-05-09
GOLDLENS(TM) (K913239)Doran Instruments, Inc.1992-01-31
DTL ELECTRODE (K844409)Sauquoit Industries, Inc.1985-02-14
ERG-JET ELECTRODE (K830557)Universo S.A.1983-03-31
GOLD FOIL ERG ELECTRODES (K820254)Cadwell Laboratories, Inc.1982-04-09
ERG-JET ELECTRODE (K813399)Nicolet Biomedical Instruments1982-01-22
MULAR GOLD LEAF ELECTRODE MODEL 7501 (K781476)Life-Tech Instruments, Inc.1978-11-15
ELECTRORETINOGRAPH (K760199)Lkc Technologies, Inc.1976-08-04

Recalls involving this device

No recalls on record reference this clearance.