The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Non-balloon Replacement Gastrostomy Kit.
| Device ID | K932295 |
| 510k Number | K932295 |
| Device Name: | NON-BALLOON REPLACEMENT GASTROSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Robert Bea |
| Correspondent | Robert Bea 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-11 |
| Decision Date | 1994-09-08 |