510(k) K761191
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