The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Sapphire Series 1p, 1l, 2l, And 2me.
Device ID | K903731 |
510k Number | K903731 |
Device Name: | SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Contact | Arthur Blumenfeld |
Correspondent | Arthur Blumenfeld TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-16 |
Decision Date | 1991-02-04 |