The following data is part of a premarket notification filed by Richmond Products, Inc. with the FDA for Head & Chin Rests.
Device ID | K873918 |
510k Number | K873918 |
Device Name: | HEAD & CHIN RESTS |
Classification | Trephine, Manual, Ophthalmic |
Applicant | RICHMOND PRODUCTS, INC. 1021 SO ROGERS CIRCLE Boca Raton, FL 33487 -2894 |
Contact | Lloyd Powell |
Correspondent | Lloyd Powell RICHMOND PRODUCTS, INC. 1021 SO ROGERS CIRCLE Boca Raton, FL 33487 -2894 |
Product Code | HRH |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-24 |
Decision Date | 1987-10-28 |