DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
FDA 510(k) clearance K970721 · decided 1997-03-21
Clearance details
- K-number
- K970721
- Device name
- DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
- Applicant
- Johnson & Johnson Medical, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-02-27
- Decision date
- 1997-03-21
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- MCY
- Device class
- 2
- Regulation number
- 880.5075
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Arlington, TX, 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 |
|---|---|---|
| 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 |
| CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER (K921347) | Medi-Flex Hospital Products, Inc. | 1993-01-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-SORB ABSORBABLE DUSTING POWDER (N6264/S003) | Johnson & Johnson Medical, Inc. | 1985-09-10 |