The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Cam-wrap(tm) New Sterilization Procedure.
| Device ID | K891983 |
| 510k Number | K891983 |
| Device Name: | CAM-WRAP(TM) NEW STERILIZATION PROCEDURE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-04-19 |