510(k) K903480
K903480 is an FDA 510(k) premarket notification submitted by Un-I-Med, Inc. for the device "HANN-VAC TM, DISPOSABLE,SUCTION CATHETER". The FDA issued a decision of Substantially Equivalent on Oct 1, 1991. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Un-I-Med, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 1, 1991
- Date Received
- Aug 2, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Suction, Tracheobronchial
- Device Class
- Class I
- Regulation Number
- 868.6810
- Review Panel
- AN
- Submission Type
- 510(k) Exempt