The following data is part of a premarket notification filed by Clearchem Corp. with the FDA for Osto-pure.
| Device ID | K871738 |
| 510k Number | K871738 |
| Device Name: | OSTO-PURE |
| Classification | Collector, Ostomy |
| Applicant | CLEARCHEM CORP. 2601 ADGATE RD. P.O. BOX 446 Lima, OH 45805 |
| Contact | Robert F Heil |
| Correspondent | Robert F Heil CLEARCHEM CORP. 2601 ADGATE RD. P.O. BOX 446 Lima, OH 45805 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-08-12 |