510(k) K801908
- Device
- Si-14
- Applicant
- KMI MEDICAL, INC.
- 510(k) number
- K801908
- Product code
- KDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-11-12
- Date received
- 1980-08-11
- Regulation
- 878.4800
- Classification name
- Instrument, Surgical, Disposable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010097171
- 3008280196
- 3014256632
- 1724474
- 3010598169
- 2529846
- 3006082230
- 3014273597
- 3009486864
- 1424263
- 3015183635
- 3035456910
- 3003596442
- 3004519921
- 3008902714
- 3009703496
- 3010452421
- 3003644849
- 3011585752
- 9617592
- 3045058049
- 3009889060
- 3021643
- 3004111573
- 3012536737
- 1824619
- 1926681
- 2011171
- 2183319
- 3004915686
- 3026197444
- 3011371465
- 3032747418
- 1522875
- 3010612620
- 1422598
- 2031000
- 3003807268
- 9616088
- 3004099493
- 1058584
- 3011137372
- 3003431869
- 3011767135
- 3045742729
- 3012314549
- 3038637162
- 3042067802
- 3016610750
- 3013410562
- 3045816907
- 3002834291
- 1043214
- 8040884
- 3008403546
- 2433012
- 3012821559
- 3014579161
- 1423395
- 3016904853
- 3035642068
- 3010041511
- 3012104006
- 3009513193
- 3013846070
- 1721504
- 3007791599
- 3004125670
- 3010611926
- 2028661
- 3003882387
- 3035380702
- 3006554788
- 1526534
- 3010160370
- 1054241
- 9611590
- 9681540
- 3044150131
- 1721676
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K936226 | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET | Meadox Medicals, Div. Boston Scientific Corp. | 1994-03-07 |
| 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 |