K914715 is an FDA 510(k) clearance for the PARALLELING GUIDES, a Guide, Surgical, Instrument (Class I — General Controls, product code FZX), submitted by Implant Corp. of America (St. Petersburg, US). The FDA issued a Cleared decision on February 16, 1994, 852 days after receiving the submission on October 18, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K914715 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 1991 |
| Decision Date | February 16, 1994 |
| Days to Decision | 852 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZX — Guide, Surgical, Instrument |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |