510(k) K780364
K780364 is an FDA 510(k) premarket notification submitted by Spica, Inc. for the device "MANIFOLD KIT". The FDA issued a decision of Substantially Equivalent on March 30, 1978. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Spica, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1978
- Date Received
- March 6, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Regulator, Pressure, Gas Cylinder
- Device Class
- Class I
- Regulation Number
- 868.2700
- Review Panel
- AN
- Submission Type