Atlas FDA

VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS

FDA 510(k) clearance K945172 · decided 1995-01-17

Clearance details

K-number
K945172
Device name
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
Applicant
Visitec Co.
Decision
Substantially Equivalent
Date received
1994-10-21
Decision date
1995-01-17
Days to decision
88 days
Clearance type
Traditional
Product code
HQX
Device class
2
Regulation number
886.3340
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Sarasota, FL, US
Third-party review
No
Expedited review
No

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STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599)Storz Ophthalmics, Inc.1995-03-02
TAMCENAN OCULAR EXPLANTS AND BANDS (K902308)Tamcenan Corp.1990-06-19
O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (K901002)Oculo Plastik, Inc.1990-05-22
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (K900929)Oculo Plastik, Inc.1990-05-18
COX MALAR EMINENCE IMPLANTS (K900928)Oculo Plastik, Inc.1990-05-15
CODERE-DURETTE ORBITAL FLOOR IMPLANT (K900927)Oculo Plastik, Inc.1990-05-15
SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (K900930)Oculo Plastik, Inc.1990-05-15

Recalls involving this device

No recalls on record reference this clearance.