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 |