510(k) K811794
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