The following data is part of a premarket notification filed by Palco Laboratories, Inc. with the FDA for Auto-lancet.
Device ID | K833344 |
510k Number | K833344 |
Device Name: | AUTO-LANCET |
Classification | Lancet, Blood |
Applicant | PALCO LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMK |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-27 |
Decision Date | 1983-11-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUTO-LANCET 73770322 not registered Dead/Abandoned |
LEVIN, PAUL D. 1988-12-19 |
AUTO-LANCET 73495414 not registered Dead/Abandoned |
LEVIN, PAUL D. 1984-08-17 |