The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Sterile View(tm) Hi Effic Helmet/back Pk Sup/exhau.
| Device ID | K914694 |
| 510k Number | K914694 |
| Device Name: | STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-18 |
| Decision Date | 1992-01-16 |