The following data is part of a premarket notification filed by Intertech/ohio with the FDA for Straight Adapt W/temp Sensing Port/closure Plug.
Device ID | K861056 |
510k Number | K861056 |
Device Name: | STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG |
Classification | Connector, Airway (extension) |
Applicant | INTERTECH/OHIO 5030 TICE ST. Fort Myers, FL 33905 |
Contact | J. E Blake |
Correspondent | J. E 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 | 1986-03-19 |
Decision Date | 1986-03-27 |