The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Mini Lancet-blood Lancet.
Device ID | K830705 |
510k Number | K830705 |
Device Name: | MINI LANCET-BLOOD LANCET |
Classification | Depressor, Tongue, Non-surgical |
Applicant | PHARMAQUEST CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMA |
CFR Regulation Number | 880.6230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-07 |
Decision Date | 1983-04-08 |