510(k) K770071

PINLOCK CONTAINER by Perkins Mfg. Co. — Product Code KDT

K770071 is an FDA 510(k) premarket notification submitted by Perkins Mfg. Co. for the device "PINLOCK CONTAINER". The FDA issued a decision of Substantially Equivalent on February 24, 1977. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. Perkins Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1977
Date Received
January 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen Mailer And Storage, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
PA
Submission Type