The following data is part of a premarket notification filed by Sandhill with the FDA for Sandhill Ams.
Device ID | K863312 |
510k Number | K863312 |
Device Name: | SANDHILL AMS |
Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Applicant | SANDHILL 224 E. OLIVE AVE. Burbank, CA 91502 |
Contact | Robert R Chambers |
Correspondent | Robert R Chambers SANDHILL 224 E. OLIVE AVE. Burbank, CA 91502 |
Product Code | FAP |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-26 |
Decision Date | 1986-12-03 |