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#
- 3009349165
- 3002834291
- 1721676
- 3031582434
- 3015161041
- 3013298431
- 3022320321
- 1226544
- 3030220356
- 3014579161
- 3012660022
- 1721504
- 3013846070
- 1220724
- 3012821559
- 1000426080
- 3003882387
- 3008719017
- 3010611926
- 1926681
- 3018097421
- 2210968
- 3005595283
- 2183785
- 3004605321
- 3010160370
- 2020735
- 3015173212
- 3012314549
- 2433012
- 3009889060
- 2028661
- 3014666579
- 3001650535
- 3008338766
- 9617592
- 2031000
- 3006554788
- 2242450
- 3015378469
- 8040263
- 3010612620
- 3009077131
- 1526534
- 3014314985
- 2024311
- 2029015
- 3005841027
- 8030607
- 1055236
- 9616088
- 9680874
- 3007597038
- 1038913
- 3011452218
- 3008280196
- 3011585752
- 3003244954
- 3004099493
- 9611612
- 3012104006
- 1030451
- 3006542849
- 3005012805
- 3014421917
- 1222274
- 3004472854
- 8022787
- 1061124
- 3045857302
- 8010251
- 1043214
- 9612030
- 3009417901
- 3015225571
- 2027062
- 3004530184
- 1057404
- 3008392711
- 9680563
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 |
| K854890 | HOOK PROBE | Euro-Med Intl. | 1986-05-02 |
| K854894 | SPOON | Euro-Med Intl. | 1986-05-02 |
| K854895 | BASKET FORCEP | Euro-Med Intl. | 1986-05-02 |
| K854896 | HOOK SCISSOR | Euro-Med Intl. | 1986-05-02 |