FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLADIATOR ANTISHOCK PANTS
K Number: K953763
·
Decision Nov 28, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
15
Review Days
109
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Basic Information
- Device Name
- GLADIATOR ANTISHOCK PANTS
- K Number
- K953763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jobst Institute, Inc.
- Date Received
- August 11, 1995
- Decision Date
- November 28, 1995
- Product Code
- LHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LHX | Trousers, Anti-Shock | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHX), ordered by most recent decision date.
TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
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FDA Class 2
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BP TRAUMA AIR PANTS
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEE LIFE SUPPORT AIR PANTS
FDA 510(k)
FDA Class 2
·Cardiovascular
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| K920444 | ULTIMATE | Apr 20, 1992 | Substantially Equivalent |
| K912232 | ULCERCARE | Aug 14, 1991 | Substantially Equivalent |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Mar 29, 1991 | Substantially Equivalent |
| K905631 | COMPRINET, COMTESSE AND BELLAVAR STOCKINGS | Mar 7, 1991 | Substantially Equivalent |