K993835 is an FDA 510(k) clearance for the PARAPOST SYSTEM STERILIZABLE ORGANIZER. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on December 16, 1999, 34 days after receiving the submission on November 12, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K993835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1999 |
| Decision Date | December 16, 1999 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |