The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Urine Specimen Container #'s 1013-1016.
| Device ID | K802002 |
| 510k Number | K802002 |
| Device Name: | URINE SPECIMEN CONTAINER #'S 1013-1016 |
| Classification | Container, Specimen, Sterile |
| Applicant | POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMH |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-20 |
| Decision Date | 1980-09-09 |