The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Richards Thermoplastic Dorsal Nasal Splint.
Device ID | K882244 |
510k Number | K882244 |
Device Name: | RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT |
Classification | Splint, Nasal |
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 | EPP |
CFR Regulation Number | 874.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-31 |
Decision Date | 1988-06-23 |