510(k) K936226
- Device
- SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- 510(k) number
- K936226
- Product code
- KDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-07
- Date received
- 1993-12-29
- Regulation
- 878.4800
- Classification name
- Instrument, Surgical, Disposable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- JANE AYOYAGI
- Address
- 112 Bauer Dr. Oakland NJ US 07045 07045
FDA Registration Numbers#
- 3004050971
- 3006950086
- 9616088
- 3004605321
- 3021477808
- 1061124
- 1000393132
- 9611590
- 3010155661
- 3045058049
- 3033589330
- 3004915909
- 1526534
- 3008403546
- 3003882387
- 2024311
- 3014023545
- 9681540
- 1000604079
- 3016904853
- 1721676
- 3008973760
- 1424263
- 9611484
- 3015161041
- 1915484
- 3044150131
- 3004125670
- 3011137372
- 3006297783
- 3009703496
- 3010452421
- 3001650535
- 1222274
- 3022555290
- 2183785
- 3005841027
- 3014456066
- 3011111237
- 1123137
- 3003431869
- 3031582434
- 9611612
- 3009889060
- 1222928
- 3014579161
- 3008338766
- 3008280196
- 3014314985
- 1250045
- 3008902714
- 1422598
- 2011171
- 3006554788
- 3010198795
- 3013602181
- 3007518347
- 3013298431
- 3011452218
- 2027062
- 3009513193
- 3009077131
- 3011767135
- 3006410968
- 1417592
- 1220477
- 3010380285
- 3011715922
- 3018097421
- 3023341288
- 2028661
- 8040373
- 3011585752
- 3022320321
- 1220724
- 1060680
- 3026197444
- 3029995792
- 3005874553
Source Documents#
Other 510(k) Records For Product Code KDC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943229 | DISPOSABLE SURGICAL SCISSORS AND FORCEPS | Y.M.K. International Co., Ltd. | 1994-08-19 |
| K920153 | THERMUFF BAG | Techstyles | 1992-07-01 |
| K920263 | MANUAL SURGICAL INSTRUMENTS | Phoenix Instruments Div. | 1992-05-06 |
| K915064 | DISPOSABLE CAUTERY ABRASIVE PAD | American Medical Mfg., Inc. | 1992-03-11 |
| K914960 | INSTRUMENT ORGANIZER | O.R. Concepts, Inc. | 1992-02-28 |
| K912834 | SHUR-GRIP | Inman Medical Corp. | 1991-07-26 |
| K910079 | DISPOSABLE INTRODUCER SHEATH | Applied Vascular Devices, Inc. | 1991-02-27 |
| K905240 | VESSELOOPS | Sparta Surgical Corp. | 1991-02-06 |
| K903649 | BRADLEY TENACULUM HOLDER | Marlo Surgical Technology | 1990-11-02 |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | Richard-Allan Medical Ind., Inc. | 1990-05-03 |
| K896676 | KEY VASCULAR LOOPS | Key Surgical, Inc. | 1990-02-27 |
| K854896 | HOOK SCISSOR | Euro-Med Intl. | 1986-05-02 |
| K854897 | MAX-I-GRASP | Euro-Med Intl. | 1986-05-02 |
| K854901 | PACIFIC GRASPER | Euro-Med Intl. | 1986-05-02 |
| K854898 | ATLANTIC GRASPER | Euro-Med Intl. | 1986-05-02 |