The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Dobbhoff(r) Single Pass Peg Kit.
| Device ID | K913784 |
| 510k Number | K913784 |
| Device Name: | DOBBHOFF(R) SINGLE PASS PEG KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Joseph Butler |
| Correspondent | Joseph Butler BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1992-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521020140 | K913784 | 000 |
| 30884521020171 | K913784 | 000 |
| 30884521020164 | K913784 | 000 |
| 20884521664064 | K913784 | 000 |
| 20884521104010 | K913784 | 000 |
| 10884521104006 | K913784 | 000 |
| 20884521007809 | K913784 | 000 |
| 10884521703018 | K913784 | 000 |
| 10884521007826 | K913784 | 000 |