APLICARE SKIN PROTECTANT PREP PAD
FDA 510(k) clearance K861557 · decided 1986-07-11
Clearance details
- K-number
- K861557
- Device name
- APLICARE SKIN PROTECTANT PREP PAD
- Applicant
- Aplicare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-25
- Decision date
- 1986-07-11
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NEC
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Madison, CT, 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 |
|---|---|---|
| SUPERSKIN (K972081) | Medlogic Global Corp. | 1997-12-17 |
| APLICARE SKIN PROTECTANT SWABSTICK (K861558) | Aplicare, Inc. | 1986-06-04 |
Recalls involving this device
No recalls on record reference this clearance.