The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Feeding Tube Placement Stylet.
Device ID | K792468 |
510k Number | K792468 |
Device Name: | FEEDING TUBE PLACEMENT STYLET |
Classification | Guide, Surgical, Instrument |
Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FZX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-03 |
Decision Date | 1979-12-27 |