510(k) K972034
- Device
- MEDPOR OCULAR CONFORMER
- Applicant
- POREX SURGICAL, INC.
- 510(k) number
- K972034
- Product code
- HQN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-20
- Date received
- 1997-06-02
- Regulation
- 886.3130
- Classification name
- Conformer, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD MERCER
- Address
- 500 Bohannon Rd. Fairburn GA US 30213 30213
FDA Registration Numbers#
- 1058584
- 1932180
- 1824736
- 3007096749
- 2518410
- 2245590
- 3004215117
- 2183958
- 3042953262
- 3019541696
- 2183831
- 2027377
- 8022166
- 2183957
- 2028523
- 3003951061
- 1000220575
- 3042228518
- 3010162973
- 2242450
- 1018470
- 9615745
- 3006550126
- 2246552
- 3004467263
- 1226544
- 2183955
- 1313525
- 3015177648
- 3002991496
- 8010177
- 3005528784
- 2031962
Source Documents#
Other 510(k) Records For Product Code HQN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970318 | OCULAR CONFORMER | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| K970319 | OCULAR CONFORMER | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| K945110 | KOLBERG OPHTHALMIC CONFORMER | Kolberg Ocular Products, Inc. | 1995-01-13 |
| K921221 | STERILE/SINGLE USE SYMBLEPHARON RING | Storz Instrument Co. | 1992-07-17 |
| K921229 | STERILE/SINGLE USE OPHTHALMIC CONFORMERS | Storz Instrument Co. | 1992-06-09 |
| K772168 | MOLDEYE | Robert B. Scott Ocularists of Florida, Inc. | 1977-11-30 |
Legacy Summary#
summary
FDA Review#
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