The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Infusion Manifold.
Device ID | K873852 |
510k Number | K873852 |
Device Name: | INFUSION MANIFOLD |
Classification | Tubing, Fluid Delivery |
Applicant | ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
Contact | Todd J Hessel |
Correspondent | Todd J Hessel ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
Product Code | FPK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-22 |
Decision Date | 1987-11-23 |