REPROCESSED COMPRESSION LIMB SLEEVES
FDA 510(k) clearance K012658 · decided 2002-05-14
Clearance details
- K-number
- K012658
- Device name
- REPROCESSED COMPRESSION LIMB SLEEVES
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2002-05-14
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. recall (Z-1638-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |