The following data is part of a premarket notification filed by Paragon Medical, Inc. with the FDA for Paragon Medical Surgical Instrument Delivery System Various.
| Device ID | K032119 |
| 510k Number | K032119 |
| Device Name: | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | PARAGON MEDICAL, INC. 7822 LADUE GLEN Fort Wayne, IN 46804 |
| Contact | David C Furr |
| Correspondent | David C Furr PARAGON MEDICAL, 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 | 2003-07-09 |
| Decision Date | 2003-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554033410 | K032119 | 000 |
| 00847399015921 | K032119 | 000 |
| 00847399005878 | K032119 | 000 |
| 00847399003782 | K032119 | 000 |
| 00847399017345 | K032119 | 000 |
| 00847399006295 | K032119 | 000 |
| 00847399004840 | K032119 | 000 |