510(k) K962789
- Device
- SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
- Applicant
- SMITH & NEPHEW ENDOSCOPY, INC.
- 510(k) number
- K962789
- Product code
- GEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-14
- Date received
- 1996-07-17
- Regulation
- 878.4820
- Classification name
- Motor, Surgical Instrument, Ac-powered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TEDD GOSIAN
- Address
- 130 Forbes Blvd. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 2245304
- 3006985163
- 3011534620
- 9610617
- 9614446
- 3015967359
- 2032809
- 3025141
- 3032391
- 1219602
- 3011922183
- 3030412764
- 1054713
- 1020279
- 8031000
- 3007047889
- 9611283
- 1045834
- 1226544
- 1054811
- 1828288
- 3015504568
- 2648666
- 1226486
- 1822565
- 3015610860
- 3003244954
- 3009381954
- 3009672666
- 3010707607
- 1030489
- 2183744
- 8010697
- 1032347
- 3004142400
- 3007279848
- 3034246209
- 3018940271
- 3017604
- 3008102042
- 3018318562
- 3015376465
- 3027728872
- 3007024186
- 3009039068
- 9680741
- 3006801265
- 3010097171
- 1836161
- 3002807315
- 3002807310
- 3011300255
- 3023155873
- 3002907620
- 1526439
- 3006438441
- 2529846
- 3010232390
- 3007997036
- 3005381997
- 1043653
- 3010446656
- 3014579188
- 3033509898
- 3013493300
- 8010177
- 3005900820
- 1828464
- 3012447612
- 3008744062
- 3013893019
- 2085947
- 1423507
- 1058584
- 1818910
- 3007958831
- 9617840
- 8010379
- 3010202439
Source Documents#
Other 510(k) Records For Product Code GEY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050519 | ADVANCED TURBO DRIVE SYSTEM | Linvatec Corp. | 2005-05-17 |
| K020621 | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | Arthrocare Corp. | 2002-03-28 |
| K012738 | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | Depuyacromed | 2001-11-14 |
| K972308 | MEDNEXT 1000 DRILL | Mednext, Inc. | 1997-08-20 |
| K971941 | AQUA SPRAY | Boyd Industries, Inc. | 1997-08-14 |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Biomedical Ent., Inc. | 1997-07-29 |
| K971268 | BONE & MARROW CLLECTION SYSTEM | Biomedical International Corp. | 1997-07-03 |
| K964252 | ORTHOCHUCK | Buckman Co., Inc. | 1997-05-27 |
| K970530 | ANSPACH LUBRICATING SYSTEM II | The Anspach Effort, Inc. | 1997-05-05 |
| K964073 | BME BONE DRILL BITS | Biomedical Ent., Inc. | 1996-11-14 |
| K961901 | BONE & MARROW COLLECTION SYSTEM | Biomedical Ent., Inc. | 1996-08-06 |
| K954470 | SURGIMOTOR | W.O.M. World of Medicine GmbH | 1995-12-08 |
| K951773 | PODOSPRAY DRILL SYSTEM | Darco Intl., Inc. | 1995-10-26 |
| K952008 | KARL STORZ DRILL | KARL STORZ Endoscopy-America, Inc. | 1995-07-26 |
| K951118 | 3M MAXI-DRIVER II ELECTRIC SYSTEM | 3M Company | 1995-07-06 |
Legacy Summary#
summary
FDA Review#
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