The following data is part of a premarket notification filed by Specialty Packaging Producs, Inc. with the FDA for Disposable Anesthesia Breathing Circuit.
Device ID | K910896 |
510k Number | K910896 |
Device Name: | DISPOSABLE ANESTHESIA BREATHING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | SPECIALTY PACKAGING PRODUCS, INC. 19 LEIGH FISHER El Paso, TX 79906 |
Contact | Edward F Valdez |
Correspondent | Edward F Valdez SPECIALTY PACKAGING PRODUCS, INC. 19 LEIGH FISHER El Paso, TX 79906 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-04 |
Decision Date | 1991-05-08 |