The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Mvs Fiberoptic Lightpipe.
Device ID | K870942 |
510k Number | K870942 |
Device Name: | MVS FIBEROPTIC LIGHTPIPE |
Classification | Light, Surgical, Fiberoptic |
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 | FST |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-09 |
Decision Date | 1987-04-03 |