The following data is part of a premarket notification filed by Curwood, Inc. with the FDA for Medi-oxide Sterilzation Pouch From Medi-plus.
| Device ID | K953749 |
| 510k Number | K953749 |
| Device Name: | MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CURWOOD, INC. 2200 BADGER AVE. Oshkosh, WI 54904 |
| Contact | Matthew A Mielke |
| Correspondent | Matthew A Mielke CURWOOD, INC. 2200 BADGER AVE. Oshkosh, WI 54904 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-11 |
| Decision Date | 1995-10-19 |