The following data is part of a premarket notification filed by R.h. Burton Co. with the FDA for 910t Montorized Instrument Table.
Device ID | K922242 |
510k Number | K922242 |
Device Name: | 910T MONTORIZED INSTRUMENT TABLE |
Classification | Table, Instrument, Powered, Ophthalmic |
Applicant | R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
Contact | Tammy Kern |
Correspondent | Tammy Kern R.H. BURTON CO. 3965 BROOKHAM DR. P.O. BOX 68 Grove City, OH 43123 |
Product Code | HRJ |
CFR Regulation Number | 886.4855 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-13 |
Decision Date | 1992-09-30 |