The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Richard Arthroscope.
Device ID | K843604 |
510k Number | K843604 |
Device Name: | RICHARD ARTHROSCOPE |
Classification | Arthroscope |
Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Robert F Games |
Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-13 |
Decision Date | 1984-10-22 |