510(k) K982599
- Device
- THE FREMSTAD RING
- Applicant
- OPHTHALMIC SOLUTIONS, LLC.
- 510(k) number
- K982599
- Product code
- HOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-16
- Date received
- 1998-07-27
- Regulation
- 886.4790
- Classification name
- Sponge, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DARIA A FREMSTAD
- Address
- 2179 Northlake Pkwy., Bldg. 5 Suite 115 Tucker GA US 30084 30084
FDA Registration Numbers#
- 8043396
- 2029275
- 1222313
- 2244478
- 2027619
- 3006234743
- 3005391805
- 1052728
- 3013004948
- 3015177648
- 3009403363
- 3018094310
- 1319639
- 1054241
- 1928237
- 3012620142
- 1220477
- 1058726
- 1219313
- 3011164728
- 3013421458
- 1929756
- 1226074
- 1055236
- 9680271
- 1211998
- 1649518
- 3009337401
- 2083373
- 3004911384
- 3012185136
- 2085081
- 3008719017
- 3010807315
- 3013466775
- 2027062
- 1219071
- 3016678045
- 3017475063
- 2022435
- 1060680
- 3016904853
- 1043214
- 2320762
- 3004215117
- 2246552
- 3005528784
- 3023464160
- 3019924
- 3020775387
- 2242656
- 3010610457
- 3007735241
- 2523835
- 3031231776
- 3012494290
- 3042228518
- 2032098
- 2242450
- 3010041511
- 2529846
- 2183744
- 3002468342
- 3010487482
- 3042284339
- 3008812251
- 2135152
- 3001967056
- 3004605321
- 1319660
- 1221144
- 3011137372
- 2435946
- 3024088964
- 1064005
- 3003951061
- 9611462
Source Documents#
Other 510(k) Records For Product Code HOZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132796 | SUNTOUCH EYE SPEAR | Huizhou Foryou Medical Devices Co., Ltd. | 2013-10-30 |
| K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | Network Medical Products, Ltd. | 2013-10-29 |
| K091240 | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | Alphamed, Inc. | 2009-10-23 |
| K082460 | CENEFOM PVA SURGICAL SPEAR | Longtek Scientific Co., Ltd. | 2008-12-15 |
| K012196 | ULTRACELL ABSORBENT STICK | Ultracell Medical Technologies, Inc. | 2001-08-24 |
| K011191 | MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES | Medtronic Xomed, Inc. | 2001-06-26 |
| K003842 | PRESCOTT'S SURGICAL SPEAR | Prescott'S, Inc. | 2001-04-13 |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | Med-Logics, Inc. | 2000-08-18 |
| K993883 | M-PACT CORNEAL LIGHT SHIELD | M-Pact Corp. | 1999-12-21 |
| K990671 | DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE | Hurricane Medical | 1999-05-10 |
| K990749 | SOF-SUCTION FLUID EVACUATION SYSTEM | X-Tech Medical, LLC | 1999-04-02 |
| K974313 | HYDROFERA SURGICAL SPEAR | Hydrofera, LLC | 1998-03-02 |
| K972633 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | Deroyal Industries, Inc. | 1997-09-30 |
| K971832 | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK | M-Pact Worldwide Management Corp. | 1997-07-31 |
Legacy Summary#
summary
FDA Review#
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