The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Mvs 2.5mm, 4.0mm, 6.0mm Infusion Cannula.
Device ID | K871605 |
510k Number | K871605 |
Device Name: | MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA |
Classification | Cannula, Ophthalmic |
Applicant | ADVANCED SURGICAL PRODUCTS, INC. 524 CHELE DRIVE ST. Charles, MO 63303 |
Contact | Todd Hessel |
Correspondent | Todd Hessel ADVANCED SURGICAL PRODUCTS, INC. 524 CHELE DRIVE ST. Charles, MO 63303 |
Product Code | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-24 |
Decision Date | 1987-06-19 |