The following data is part of a premarket notification filed by Robert I. Chien & Assoc., Inc. with the FDA for Rica (diagnostic Instruments).
Device ID | K810054 |
510k Number | K810054 |
Device Name: | RICA (DIAGNOSTIC INSTRUMENTS) |
Classification | Percussor |
Applicant | ROBERT I. CHIEN & ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GWZ |
CFR Regulation Number | 882.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-12 |
Decision Date | 1981-01-28 |