510(k) K760602

SORVALL EMBEDDING MEDIUM by E.I. Dupont DE Nemours & Co., Inc. — Product Code KEO

K760602 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "SORVALL EMBEDDING MEDIUM". The FDA issued a decision of Substantially Equivalent on September 21, 1976. The device falls under product code KEO (Formulations, Paraffin, All), a Class I device regulated under 21 CFR 864.4010. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1976
Date Received
September 7, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Paraffin, All
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type