ROUTINE DRESSING TRAY
FDA 510(k) clearance K902811 · decided 1990-09-25
Clearance details
- K-number
- K902811
- Device name
- ROUTINE DRESSING TRAY
- Applicant
- Orion Life Systems, Inc.
- Decision
- Unknown
- Date received
- 1990-06-27
- Decision date
- 1990-09-25
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MCY
- Device class
- 2
- Regulation number
- 880.5075
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wheeling, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Orion Life Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM (K970721) | Johnson & Johnson Medical, Inc. | 1997-03-21 |
| CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (K963719) | Grand Medical Products | 1996-11-27 |
| WOUND CARE COMPRESSION SYSTEM (WCCS) (K960585) | Suncoast Medical Products, Inc. | 1996-04-26 |
| DRESSING CHANGE TRAY (K952334) | Busse Hospital Disposables, Inc. | 1995-07-14 |
| CIRCULON SYSTEM STEP 1 (K951022) | Convatec, A Division of E.R. Squibb & Sons | 1995-06-12 |
| CIRCULON SYSTEM STEP 2 (K951021) | Convatec, A Division of E.R. Squibb & Sons | 1995-06-12 |
| E-PACK PROCEDURE KITS (K951476) | ETHICON, Inc. | 1995-05-23 |
| DRESSING CHANGE TRAY-MODIFIED (K931932) | Medsurg Industries, Inc. | 1993-08-27 |
| VARIOUS NON-STERILE CUSTOM TRAYS/KITS (K924690) | Surgipro Central, Inc. | 1993-07-16 |
| WOUND DRESSING KIT (K923905) | Kit Pak, Inc. | 1993-07-02 |
| TPN TRAY (STERILE) (K925021) | Customed, Inc. | 1993-06-07 |
| PER-Q-CATH DRESSING CHANGE TRAY (K926063) | Gesco Intl., Inc. | 1993-06-07 |
Recalls involving this device
No recalls on record reference this clearance.