The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Anabag.
Device ID | K871238 |
510k Number | K871238 |
Device Name: | ANABAG |
Classification | Device, Gas Generating |
Applicant | SCOTT LABORATORIES, INC. Fiskeville, RI 02823 |
Contact | Paul Campognone |
Correspondent | Paul Campognone SCOTT LABORATORIES, INC. Fiskeville, RI 02823 |
Product Code | KZJ |
CFR Regulation Number | 866.2580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-27 |
Decision Date | 1987-04-03 |