510(k) K790102
- Device
- Model 556-01 Cryoextractor
- Applicant
- INTERMEDICS, INC.
- 510(k) number
- K790102
- Product code
- HPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-02-12
- Date received
- 1979-01-16
- Regulation
- 886.4170
- Classification name
- Unit, Cryophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1218813
- 3012037425
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202038 | CryoTreQ | VitreQ BV | 2020-12-30 |
| K940373 | OPHTHALMIC CRYO UNIT | Dutch Ophthalmic USA, Inc. | 1994-07-18 |
| K923629 | OPHTHALMIC TRICHIASIS PROBE | Mira, Inc. | 1992-10-19 |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | Spembly Medical , Ltd. | 1990-10-11 |
| K874555 | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | Keeler Instruments, Inc. | 1988-01-29 |
| K873388 | KEELER CTU CRYO SYSTEM | Keeler Instruments, Inc. | 1987-11-13 |
| K870195 | UNITED SURGICAL CORP. CRYOPTIC PLUS | United Surgical Corp. | 1987-02-20 |
| K833747 | GALLIE CRYONUCLEATOR | Mono Research Laboratories | 1984-05-09 |
| K801418 | KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT | Keeler Optical Products , Ltd. | 1980-07-21 |
| K781338 | BEAVER CATARACT CYROXTRACTOR | Edward Weck, Inc. | 1979-02-12 |