The following data is part of a premarket notification filed by Technology Marketing Group with the FDA for Tas-(various) Ultrathin Flexible Endoscope.
Device ID | K942388 |
510k Number | K942388 |
Device Name: | TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | TECHNOLOGY MARKETING GROUP 525 PALMER AVE. Maywood, NJ 07607 |
Contact | Thomas Hynes |
Correspondent | Thomas Hynes TECHNOLOGY MARKETING GROUP 525 PALMER AVE. Maywood, NJ 07607 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-19 |
Decision Date | 1994-08-17 |