GLADIATOR ANTISHOCK PANTS
FDA 510(k) clearance K953763 · decided 1995-11-28
Clearance details
- K-number
- K953763
- Device name
- GLADIATOR ANTISHOCK PANTS
- Applicant
- Jobst Institute, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-11
- Decision date
- 1995-11-28
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- LHX
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Charlotte, NC, 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 |
|---|---|---|
| TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS (K874774) | Vinyl Technology, Inc. | 1988-02-08 |
| BP TRAUMA AIR PANTS (K841605) | Bp Medical Systems, Inc. | 1984-07-06 |
| ZEE LIFE SUPPORT AIR PANTS (K812564) | Zee Medical Products Co., Inc. | 1981-10-23 |
Recalls involving this device
No recalls on record reference this clearance.