510(k) K841491
K841491 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "CONVENTIONAL PLASTIC DENTAL TRAYS". The FDA issued a decision of Substantially Equivalent on July 13, 1984. The device falls under product code EHY (Tray, Impression, Preformed), a Class I device regulated under 21 CFR 872.6880. Buffalo Dental Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1984
- Date Received
- April 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Impression, Preformed
- Device Class
- Class I
- Regulation Number
- 872.6880
- Review Panel
- DE
- Submission Type