510(k) K862725
K862725 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "SACCOMANNO SPECIMAN SOLUTION". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code LDZ (Fixative, Alcohol Containing), a Class I device regulated under 21 CFR 864.4010. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1986
- Date Received
- July 17, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixative, Alcohol Containing
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type