510(k) K910896
K910896 is an FDA 510(k) premarket notification submitted by Specialty Packaging Producs, Inc. for the device "DISPOSABLE ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on May 8, 1991. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Specialty Packaging Producs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1991
- Date Received
- March 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Device Class
- Class I
- Regulation Number
- 868.5240
- Review Panel
- AN
- Submission Type