The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Daisy Protected Scalp Vein Set.
Device ID | K992999 |
510k Number | K992999 |
Device Name: | DAISY PROTECTED SCALP VEIN SET |
Classification | Set, Administration, Intravascular |
Applicant | DIASOL, INC. 13212 RAYMER ST. North Hollywood, CA 91605 |
Contact | Monica Abeles |
Correspondent | Monica Abeles DIASOL, INC. 13212 RAYMER ST. North Hollywood, CA 91605 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-09-07 |
Decision Date | 1999-11-05 |