510(k) K971242
- Device
- BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
- Applicant
- IPAX, INC.
- 510(k) number
- K971242
- Product code
- MML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-17
- Date received
- 1997-04-02
- Regulation
- 886.5700
- Classification name
- Weights, Eyelid, External
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PHIL PENNELL
- Address
- 2109 W. Amherst Ave. Englewood CO US 80110 80110
FDA Registration Numbers#
- 8010617
- 3002858762
- 8044131
- 3008812251
- 3009217531
- 9615745
- 1926681
- 2242450
- 3004467263
- 9614107
- 9612327
- 8031058
- 2921577
- 3002991496
- 3008132398
- 9611665
- 2029275
- 3042228518
Source Documents#
Other 510(k) Records For Product Code MML #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170591 | Altomed Malhotra Platinum Segments | Altomed Limited | 2017-06-06 |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | 2015-08-17 |
| K021750 | LID CHAIN EYELID WEIGHTS | Jedmed Instrument Co. | 2003-01-27 |
| K011740 | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | Meddev Corp. | 2001-07-02 |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | Heinz Kurz GmbH Medizintechnik | 2001-05-02 |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Iop, Inc. | 2001-02-22 |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | Heinz Kurz GmbH Medizintechnik | 2000-04-21 |
| K994289 | SUTUREGROOVE | Iop, Inc. | 2000-04-17 |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | Heinz Kurz GmbH Medizintechnik | 2000-04-12 |
| K990224 | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | Labtician Ophthalmics, Inc. | 1999-04-12 |
| K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | Labtician Ophthalmics, Inc. | 1999-01-08 |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Ipax, Inc. | 1997-06-20 |
| K940974 | EYECLOSE EXTERNAL EYELID WEIGHTS | Meddev Corp. | 1994-06-08 |
Legacy Summary#
summary
FDA Review#
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