The following data is part of a premarket notification filed by Palco Laboratories, Inc. with the FDA for Inject-ease.
Device ID | K872233 |
510k Number | K872233 |
Device Name: | INJECT-EASE |
Classification | Introducer, Syringe Needle |
Applicant | PALCO LABORATORIES, INC. 1595 SOQUEL DR. Santa Cruz, CA 95065 |
Contact | Levin, M.d. |
Correspondent | Levin, M.d. PALCO LABORATORIES, INC. 1595 SOQUEL DR. Santa Cruz, CA 95065 |
Product Code | KZH |
CFR Regulation Number | 880.6920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-10 |
Decision Date | 1987-09-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00025294874007 | K872233 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INJECT-EASE 73770310 1557817 Live/Registered |
LEVIN, PAUL D. 1988-12-19 |