The following data is part of a premarket notification filed by New Dimensions In Medicine, Inc. with the FDA for Clearsite Hydrogel Wound Dressing Modification.
| Device ID | K920677 |
| 510k Number | K920677 |
| Device Name: | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | NEW DIMENSIONS IN MEDICINE, INC. P.O. BOX 1408 3040 EAST RIVER ROAD Dayton, OH 45401 |
| Contact | Donald E Koopman |
| Correspondent | Donald E Koopman NEW DIMENSIONS IN MEDICINE, INC. P.O. BOX 1408 3040 EAST RIVER ROAD Dayton, OH 45401 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-14 |
| Decision Date | 1992-04-21 |