BARRIER HIP PACK W/ FABRIC 450
FDA 510(k) clearance K780282 · decided 1978-02-28
Clearance details
- K-number
- K780282
- Device name
- BARRIER HIP PACK W/ FABRIC 450
- Applicant
- Surgikos, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-21
- Decision date
- 1978-02-28
- Days to decision
- 7 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Barrier Hip Sheet with Side Pockets recall (Z-1137-03) | Molnlycke Health Care Inc | 2003-08-14 |