The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Provial Ii #006-010-0201.
Device ID | K823773 |
510k Number | K823773 |
Device Name: | PROVIAL II #006-010-0201 |
Classification | Container, Specimen Mailer And Storage, Sterile |
Applicant | DYNATECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDT |
CFR Regulation Number | 864.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-14 |
Decision Date | 1983-01-21 |