510(k) K761191

4 1/2 OZ. GRADUATED SPECIMEN CONTAINER by Superior Plastic Products Corp. — Product Code FMH

K761191 is an FDA 510(k) premarket notification submitted by Superior Plastic Products Corp. for the device "4 1/2 OZ. GRADUATED SPECIMEN CONTAINER". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. Superior Plastic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1977
Date Received
December 6, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
HO
Submission Type