The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Contain-or.
| Device ID | K934215 |
| 510k Number | K934215 |
| Device Name: | CONTAIN-OR |
| Classification | Drape, Surgical |
| Applicant | DLP, INC. 620 WATSON, S.W., P.O. BOX 409 Grand Rapids, MI 49501 -0409 |
| Contact | Roger W Brink |
| Correspondent | Roger W Brink DLP, INC. 620 WATSON, S.W., P.O. BOX 409 Grand Rapids, MI 49501 -0409 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-30 |
| Decision Date | 1994-02-09 |