The following data is part of a premarket notification filed by Mdt Biologic Co. with the FDA for Mdt Sterigrip Disposable, Soft Cover, Light Handle.
| Device ID | K954940 |
| 510k Number | K954940 |
| Device Name: | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE |
| Classification | Light, Surgical, Accessories |
| Applicant | MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 |
| Contact | Charles O Hancock |
| Correspondent | Charles O Hancock MDT BIOLOGIC CO. 1777 EAST HENRIETTA RD. P.O. BOX 23077 Rochester, NY 14692 |
| Product Code | FTA |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-01-17 |