The following data is part of a premarket notification filed by Rexam Medical Packaging, Inc. with the FDA for Rexam Fracture Resistant Pouch.
| Device ID | K973440 |
| 510k Number | K973440 |
| Device Name: | REXAM FRACTURE RESISTANT POUCH |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | REXAM MEDICAL PACKAGING, INC. 1919 SOUTH BUTTERFIELD RD. Mundelein, IL 60060 -9735 |
| Contact | Andrea Haferkamp |
| Correspondent | Andrea Haferkamp REXAM MEDICAL PACKAGING, INC. 1919 SOUTH BUTTERFIELD RD. Mundelein, IL 60060 -9735 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-10 |
| Decision Date | 1997-10-20 |
| Summary: | summary |