510(k) K873545
K873545 is an FDA 510(k) premarket notification submitted by Commercial Products & Engineering Co. for the device "PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT". The FDA issued a decision of Substantially Equivalent on November 20, 1987. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Commercial Products & Engineering Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1987
- Date Received
- September 1, 1987
- 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