The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Re-bag Multi-use Pouch, Large & Small.
| Device ID | K954185 |
| 510k Number | K954185 |
| Device Name: | RE-BAG MULTI-USE POUCH, LARGE & SMALL |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MILTEX, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula MILTEX, INC. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-12-04 |