ANSPACH POWERED KERRISON SYSTEM (PKS)
FDA 510(k) clearance K022907 · decided 2002-10-21
Clearance details
- K-number
- K022907
- Device name
- ANSPACH POWERED KERRISON SYSTEM (PKS)
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-03
- Decision date
- 2002-10-21
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- HAD
- Device class
- 2
- Regulation number
- 882.4845
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palm Beach Gardens, FL, 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 |
|---|---|---|
| AESCULAP PNEUMATIC KERRISON (K062413) | Aesculap, Inc. | 2006-11-21 |
| STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD (K911637) | Personal Products Co. | 1991-08-02 |
Recalls involving this device
No recalls on record reference this clearance.