The following data is part of a premarket notification filed by Riley Medical, Inc. with the FDA for Metapak Multi-purpose Instrument Tray.
| Device ID | K993535 |
| 510k Number | K993535 |
| Device Name: | METAPAK MULTI-PURPOSE INSTRUMENT TRAY |
| Classification | Wrap, Sterilization |
| Applicant | RILEY MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane RILEY MEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-19 |
| Decision Date | 2001-12-07 |
| Summary: | summary |