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
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 3015173212
- 3014273597
- 2024311
- 1423537
- 1051550
- 3007113487
- 2029275
- 3011987967
- 3013410562
- 2183785
- 3009077131
- 3006538822
- 1216677
- 9680563
- 3035380702
- 3009349165
- 1423662
- 3014456066
- 3010380285
- 8040884
- 3010131578
- 3008383115
- 3009486864
- 2648623
- 3031582434
- 3006260740
- 3005874553
- 9616088
- 2011171
- 2433012
- 1018233
- 3014666579
- 9681540
- 3001650535
- 1054241
- 3010612620
- 3003597504
- 1928237
- 3004472854
- 1915484
- 3009540516
- 3010097171
- 2135147
- 3009703496
- 3014314985
- 8010273
- 3004099493
- 3009742443
- 3011371465
- 3004519921
- 1220477
- 1057404
- 3012104006
- 3015183635
- 3033858895
- 2029015
- 1422598
- 1921846
- 1045834
- 3003596442
- 3017102971
- 9611484
- 1422634
- 1123137
- 9611590
- 1055236
- 3009417901
- 3015161041
- 9680874
- 3007597038
- 3004111573
- 3014256632
- 3006542849
- 8010251
- 9617592
- 3012821559
- 1644312
- 3018097421
- 3006297783
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 |