510(k) K862725

SACCOMANNO SPECIMAN SOLUTION by Mill-Rose Laboratory — Product Code LDZ

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