The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Vascu-statt Approximator.
Device ID | K823694 |
510k Number | K823694 |
Device Name: | VASCU-STATT APPROXIMATOR |
Classification | Hemostat |
Applicant | SCANLAN INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRQ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-08 |
Decision Date | 1983-01-07 |