The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Disposable Volume Vent/anesthesia Breath Circuits.
Device ID | K921624 |
510k Number | K921624 |
Device Name: | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS |
Classification | Drain, Tee (water Trap) |
Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
Contact | Alyce P Marshall |
Correspondent | Alyce P Marshall INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
Product Code | BYH |
CFR Regulation Number | 868.5995 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-06 |
Decision Date | 1992-06-30 |