The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Vacuum Wand And Uni-reader.
Device ID | K821644 |
510k Number | K821644 |
Device Name: | VACUUM WAND AND UNI-READER |
Classification | System, Communication, Non-powered |
Applicant | FRED SAMMONS, INC. 145 TOWER DR. Burr Ridge, IL 60521 |
Contact | Clark L Sabine |
Correspondent | Clark L Sabine FRED SAMMONS, INC. 145 TOWER DR. Burr Ridge, IL 60521 |
Product Code | ILP |
CFR Regulation Number | 890.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-03 |
Decision Date | 1982-06-11 |