The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Enteral Feeding Tube.
Device ID | K051480 |
510k Number | K051480 |
Device Name: | ENTERAL FEEDING TUBE |
Classification | Tube, Nasogastric |
Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. Branchburg, NJ 08876 |
Contact | Gene Boyd |
Correspondent | Gene Boyd BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. Branchburg, NJ 08876 |
Product Code | BSS |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-03 |
Decision Date | 2005-10-12 |