The following data is part of a premarket notification filed by Btp Industries, Inc. with the FDA for Btp(tm) Centraline(tm) Suit.
| Device ID | K914615 |
| 510k Number | K914615 |
| Device Name: | BTP(TM) CENTRALINE(TM) SUIT |
| Classification | Suit, Surgical |
| Applicant | BTP INDUSTRIES, INC. P.O. BOX 2357 S. Hamilton, MA 01982 |
| Contact | George A Herbster |
| Correspondent | George A Herbster BTP INDUSTRIES, INC. P.O. BOX 2357 S. Hamilton, MA 01982 |
| Product Code | FXO |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-17 |
| Decision Date | 1992-05-05 |