510(k) K873009
- Device
- CONCEPT SWITCHING STICK
- Applicant
- CONCEPT, INC.
- 510(k) number
- K873009
- Product code
- KGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-17
- Date received
- 1987-08-04
- Regulation
- 878.4200
- Classification name
- Accessories, Catheter
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LORI COLVIN
- Address
- 12707 U.S. 19 S. Clearwater FL US 33546 33546
FDA Registration Numbers#
- 1123137
- 8022978
- 3023657851
- 3009211636
- 9611112
- 3034669683
- 1450395
- 1825146
- 9680794
- 3005595283
- 1911916
- 3005580113
- 1625425
- 2011171
- 9612030
- 3017103427
- 1061124
- 3013666218
- 3008258694
- 8022210
- 3005034064
- 3024891479
- 2032809
- 3005726841
- 8040278
- 3010041511
- 2028924
- 3008806809
- 3010170586
- 2182269
- 3010432890
- 3015924373
- 3010131137
- 3015859709
- 3015173212
- 3012536737
- 3004111573
- 1000121056
- 3008048800
- 3010594263
- 1054811
- 2030624
- 1724474
- 3004519921
- 3033589330
- 3013764800
- 1723241
- 3006142527
- 3010034780
- 1417485
- 3012101947
- 2320762
- 1054241
- 9681129
- 3009381954
- 3007830707
- 2124215
- 2183744
- 3005273623
- 9611665
- 3005334138
- 9617594
- 3017102971
- 3004116032
- 3010308146
- 3006673317
- 3008102042
- 3008307705
- 3016734145
- 1450662
- 9614279
- 3012568936
- 3009039068
- 3011987967
- 3013666336
- 3005669815
- 1928237
- 3006260740
- 1836161
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022306 | AART SILICONE TUBING | Aesthetic and Reconstructive Technologies, Inc. | 2002-10-10 |
| K974295 | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | Byron Medical | 1998-02-10 |
| K973183 | WOUND DRAINAGE HOLDER | R & D Medical Products, Inc. | 1998-01-23 |
| K955433 | DURALASTIC SILICONE TUBING | Allied Biomedical Corp. | 1996-01-26 |
| K942315 | NAVARRE PERCUTANEOUS ACCESS SET | Navarre Biomedical , Ltd. | 1994-07-08 |
| K896087 | PALESTRANT IRRIGATION AND DRAINAGE SET | North American Instrument Corp. | 1989-11-03 |
| K895041 | OPTICAL CATHETER(TM) INTRODUCER SETS | Medical Dynamics, Inc. | 1989-10-16 |
| K893406 | DESERET PRN ADAPTER | Deseret Medical, Inc. | 1989-06-22 |
| K870014 | HCI GENERAL PURPOSE CATHETER STYLET | Health Care Innovations, Inc. | 1987-02-06 |
| K864115 | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU | Cathaid, Inc. | 1986-11-07 |
| K855078 | ANGIO MED DISPOSABLE PRESSURE CONNECTORS | Angiomed U.S., Inc. | 1986-02-19 |
| K842666 | NU-THOR THORACOSTOMY KIT | Intl. Medical Devices , Ltd. | 1984-09-20 |
| K821525 | DESERET UNIVERSAL LUER LOCK | Warner-Lambert Co. | 1982-06-23 |
| K821245 | DESERET OFFSET PRN ADAPTER | Warner-Lambert Co. | 1982-05-13 |
| K810531 | PERI-PATCH PERITONEAL CATHETER EXTENSION | Quinton, Inc. | 1981-03-24 |
Legacy Summary#
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FDA Review#
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