The following data is part of a premarket notification filed by Mdt Biologic Co. with the FDA for Access (powerclave).
| Device ID | K954736 |
| 510k Number | K954736 |
| Device Name: | ACCESS (POWERCLAVE) |
| Classification | Sterilizer, Steam |
| 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 | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-08-15 |
| Summary: | summary |