The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Dobbhoff Anorect Biofeed Syst Five Div Fecal Const.
| Device ID | K913736 |
| 510k Number | K913736 |
| Device Name: | DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Alan Wasielewski |
| Correspondent | Alan Wasielewski BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-20 |
| Decision Date | 1992-02-07 |