The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Microinfusor.
Device ID | K932306 |
510k Number | K932306 |
Device Name: | MICROINFUSOR |
Classification | System, Gastrointestinal Motility (electrical) |
Applicant | SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Contact | Judy K Griffith |
Correspondent | Judy K Griffith SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton, CO 80120 -4535 |
Product Code | FFX |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-11 |
Decision Date | 1994-04-01 |