The following data is part of a premarket notification filed by Ever Scientific with the FDA for Glucose Tolerance Beverage.
Device ID | K042183 |
510k Number | K042183 |
Device Name: | GLUCOSE TOLERANCE BEVERAGE |
Classification | Drink, Glucose Tolerance |
Applicant | EVER SCIENTIFIC 7 WETHERILL LANE Chester Springs, PA 19425 |
Contact | Jay Reinhardt |
Correspondent | Jay Reinhardt EVER SCIENTIFIC 7 WETHERILL LANE Chester Springs, PA 19425 |
Product Code | MRV |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-11 |
Decision Date | 2004-10-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20859047006100 | K042183 | 000 |
20859047006018 | K042183 | 000 |
20859047006025 | K042183 | 000 |
20859047006032 | K042183 | 000 |
20859047006049 | K042183 | 000 |
20859047006056 | K042183 | 000 |
20859047006063 | K042183 | 000 |
20859047006070 | K042183 | 000 |
20859047006087 | K042183 | 000 |
20859047006094 | K042183 | 000 |
20859047006001 | K042183 | 000 |