The following data is part of a premarket notification filed by Landmark Plastics with the FDA for Tumbler, General Medical Medi-pak.
| Device ID | K760491 |
| 510k Number | K760491 |
| Device Name: | TUMBLER, GENERAL MEDICAL MEDI-PAK |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | LANDMARK PLASTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-23 |
| Decision Date | 1976-09-15 |