510(k) K820061
K820061 is an FDA 510(k) premarket notification submitted by Belport Co., Inc. for the device "REVERSIBLE HYDROCOLLOID IMPRESSION MAT". The FDA issued a decision of Substantially Equivalent on Feb 22, 1982. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Belport Co., Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 1982
- Date Received
- Jan 11, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type
- 510(k)