The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for New Connector & Cover For Telectronics 8mm Unipola.
Device ID | K851460 |
510k Number | K851460 |
Device Name: | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA |
Classification | Flowmeter, Calibration, Gas |
Applicant | TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
Contact | William C Nealon |
Correspondent | William C Nealon TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
Product Code | BXY |
CFR Regulation Number | 868.2350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-11 |
Decision Date | 1985-05-10 |