The following data is part of a premarket notification filed by Industrias Palex C/o Dma Med-chem Corp. with the FDA for Palex (r) Ostomy.
| Device ID | K871628 |
| 510k Number | K871628 |
| Device Name: | PALEX (R) OSTOMY |
| Classification | Collector, Ostomy |
| Applicant | INDUSTRIAS PALEX C/O DMA MED-CHEM CORP. 60 CUTTER MILL RD. SUITE 514 Great Neck, NY 11021 |
| Contact | Leo R Mindick |
| Correspondent | Leo R Mindick INDUSTRIAS PALEX C/O DMA MED-CHEM CORP. 60 CUTTER MILL RD. SUITE 514 Great Neck, NY 11021 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-07-08 |