The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Sterile View(tm) Knee-high Boots/depuy Shoe Boots.
| Device ID | K914702 |
| 510k Number | K914702 |
| Device Name: | STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS |
| Classification | Cover, Shoe, Operating-room |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | A Kotkovetz |
| Correspondent | A Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | FXP |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1993-01-29 |