The following data is part of a premarket notification filed by Intertech/ohio with the FDA for 90 Degree Elbow & Straight Connector.
Device ID | K860650 |
510k Number | K860650 |
Device Name: | 90 DEGREE ELBOW & STRAIGHT CONNECTOR |
Classification | Connector, Airway (extension) |
Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
Contact | Blake |
Correspondent | Blake INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-21 |
Decision Date | 1986-03-28 |