K870842 is an FDA 510(k) clearance for the SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP. This device is classified as a File (Class I - General Controls, product code HTP).
Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 27, 1987, 85 days after receiving the submission on March 3, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K870842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1987 |
| Decision Date | May 27, 1987 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HTP — File |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |