510(k) K895562
K895562 is an FDA 510(k) premarket notification submitted by Pemaco, Inc. for the device "PEMACO 2000 INTRAORAL DENTAL WAX". The FDA issued a decision of Substantially Equivalent on November 6, 1989. The device falls under product code EGD (Wax, Dental, Intraoral), a Class I device regulated under 21 CFR 872.6890. Pemaco, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1989
- Date Received
- September 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Dental, Intraoral
- Device Class
- Class I
- Regulation Number
- 872.6890
- Review Panel
- DE
- Submission Type