The following data is part of a premarket notification filed by Biolog, Inc. with the FDA for Jembec Transport System.
Device ID | K811283 |
510k Number | K811283 |
Device Name: | JEMBEC TRANSPORT SYSTEM |
Classification | System, Transport, Aerobic |
Applicant | BIOLOG, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JTW |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-08 |
Decision Date | 1981-06-12 |