510(k) K771749
K771749 is an FDA 510(k) premarket notification submitted by New Dimensions IN Medicine, Inc. for the device "AMALGAM DISPENSER". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code EHE (Dispenser, Mercury And/Or Alloy), a Class I device regulated under 21 CFR 872.3080. New Dimensions IN Medicine, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1977
- Date Received
- September 15, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dispenser, Mercury And/Or Alloy
- Device Class
- Class I
- Regulation Number
- 872.3080
- Review Panel
- DE
- Submission Type