The following data is part of a premarket notification filed by Symmetry Medical Usa Inc. with the FDA for Polyvac Instrument Delivery System.
| Device ID | K040223 |
| 510k Number | K040223 |
| Device Name: | POLYVAC INSTRUMENT DELIVERY SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SYMMETRY MEDICAL USA INC. 7822 LADUE GLEN Fort Wayne, IN 46804 |
| Contact | David Furr |
| Correspondent | David Furr SYMMETRY MEDICAL USA INC. 7822 LADUE GLEN Fort Wayne, IN 46804 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-02 |
| Decision Date | 2004-10-22 |
| Summary: | summary |