510(k) K931352
K931352 is an FDA 510(k) premarket notification submitted by George M. Wilson, Dds for the device "PEDO JACKETS OR PJ'S". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code ELZ (Crown, Preformed), a Class I device regulated under 21 CFR 872.3330. George M. Wilson, Dds has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1993
- Date Received
- March 17, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3330
- Review Panel
- DE
- Submission Type