The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for P.t.i. Dressing Change Trays.
| Device ID | K833758 |
| 510k Number | K833758 |
| Device Name: | P.T.I. DRESSING CHANGE TRAYS |
| Classification | Patient Examination Glove |
| Applicant | PACKAGING TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-26 |
| Decision Date | 1984-01-26 |