The following data is part of a premarket notification filed by Innovations For Mechanical Ventilation, Inc. with the FDA for Male/male Luer Transfer Tubing.
Device ID | K932780 |
510k Number | K932780 |
Device Name: | MALE/MALE LUER TRANSFER TUBING |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | INNOVATIONS FOR MECHANICAL VENTILATION, INC. 8 AMHERST RD. New City, NY 10956 |
Contact | Ralph A Milliken |
Correspondent | Ralph A Milliken INNOVATIONS FOR MECHANICAL VENTILATION, INC. 8 AMHERST RD. New City, NY 10956 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1994-01-24 |