The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Stoma Measuring Device.
| Device ID | K914482 |
| 510k Number | K914482 |
| Device Name: | STOMA MEASURING DEVICE |
| Classification | Tube, Feeding |
| 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 | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1991-12-27 |