510(k) K811794

37% FORMALDEHYDE by Richard-Allan Medical Ind., Inc. — Product Code IGG

K811794 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "37% FORMALDEHYDE". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code IGG (Formaldehyde (Formalin, Formol)), a Class I device regulated under 21 CFR 864.4010. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
June 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formaldehyde (Formalin, Formol)
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type