The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Aspirating Tubing.
Device ID | K832519 |
510k Number | K832519 |
Device Name: | ASPIRATING TUBING |
Classification | Tubing, Noninvasive |
Applicant | WELLS JOHNSON CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-08 |
Decision Date | 1983-10-20 |