The following data is part of a premarket notification filed by Modern Medical Equipment Mfg., Ltd. with the FDA for Agcel Wound Dressing,agcel Burn Dressing.
| Device ID | K050842 |
| 510k Number | K050842 |
| Device Name: | AGCEL WOUND DRESSING,AGCEL BURN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
| Contact | Bob Stillman |
| Correspondent | Bob Stillman MODERN MEDICAL EQUIPMENT MFG., LTD. 1705 DABNEY ROAD Richmond, VA 23230 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-04-01 |
| Decision Date | 2006-08-02 |
| Summary: | summary |