The following data is part of a premarket notification filed by Gainor Medical with the FDA for Blood Lancet.
Device ID | K850100 |
510k Number | K850100 |
Device Name: | BLOOD LANCET |
Classification | Lancet, Blood |
Applicant | GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
Contact | Mark Gainor |
Correspondent | Mark Gainor GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
Product Code | FMK |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-11 |
Decision Date | 1987-01-29 |