510(k) K933781
K933781 is an FDA 510(k) premarket notification submitted by Hammer-Plane, Inc. for the device "ANTI-DISCONNECTION MECHANISM". The FDA issued a decision of Substantially Equivalent on September 22, 1993. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. Hammer-Plane, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1993
- Date Received
- August 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Tracheal Tube
- Device Class
- Class I
- Regulation Number
- 868.5770
- Review Panel
- AN
- Submission Type