K955084 is an FDA 510(k) clearance for the ASPACH 65,000 (MODIFICATION). This device is classified as a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I - General Controls, product code HSZ).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 17, 1996, 90 days after receiving the submission on October 19, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K955084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1995 |
| Decision Date | January 17, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |