510(k) K781486
K781486 is an FDA 510(k) premarket notification submitted by Cpac, Inc. for the device "STERI-VAC POWER UNITS". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Cpac, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1978
- Date Received
- August 28, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evacuator, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type