510(k) K962622
K962622 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "INTRA-ORAL THERMOPLASTIC SHIELD". The FDA issued a decision of Substantially Equivalent on October 1, 1996. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Medtec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1996
- Date Received
- July 5, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Protective, Personnel
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type