DURALASTIC SILICONE TUBING
FDA 510(k) clearance K955433 · decided 1996-01-26
Clearance details
- K-number
- K955433
- Device name
- DURALASTIC SILICONE TUBING
- Applicant
- Allied Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-28
- Decision date
- 1996-01-26
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KGZ
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Paso Robles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AART SILICONE TUBING (K022306) | Aesthetic and Reconstructive Technologies, Inc. | 2002-10-10 |
| BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (K974295) | Byron Medical | 1998-02-10 |
| WOUND DRAINAGE HOLDER (K973183) | R & D Medical Products, Inc. | 1998-01-23 |
| NAVARRE PERCUTANEOUS ACCESS SET (K942315) | Navarre Biomedical , Ltd. | 1994-07-08 |
| PALESTRANT IRRIGATION AND DRAINAGE SET (K896087) | North American Instrument Corp. | 1989-11-03 |
| OPTICAL CATHETER(TM) INTRODUCER SETS (K895041) | Medical Dynamics, Inc. | 1989-10-16 |
| DESERET PRN ADAPTER (K893406) | Deseret Medical, Inc. | 1989-06-22 |
| CONCEPT SWITCHING STICK (K873009) | Concept, Inc. | 1987-08-17 |
| HCI GENERAL PURPOSE CATHETER STYLET (K870014) | Health Care Innovations, Inc. | 1987-02-06 |
| TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (K864115) | Cathaid, Inc. | 1986-11-07 |
| ANGIO MED DISPOSABLE PRESSURE CONNECTORS (K855078) | Angiomed U.S., Inc. | 1986-02-19 |
| NU-THOR THORACOSTOMY KIT (K842666) | Intl. Medical Devices , Ltd. | 1984-09-20 |
Recalls involving this device
No recalls on record reference this clearance.