The following data is part of a premarket notification filed by Canadian Theatre Products Ltd. with the FDA for O'regan Disposable Anoscope.
| Device ID | K020702 |
| 510k Number | K020702 |
| Device Name: | O'REGAN DISPOSABLE ANOSCOPE |
| Classification | Anoscope And Accessories |
| Applicant | CANADIAN THEATRE PRODUCTS LTD. #210-828 HARBOUSIDE DR. North Vancouver, B.c., CA V7p 3r9 |
| Contact | Ann-marie O'keefe |
| Correspondent | Ann-marie O'keefe CANADIAN THEATRE PRODUCTS LTD. #210-828 HARBOUSIDE DR. North Vancouver, B.c., CA V7p 3r9 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-04 |
| Decision Date | 2002-03-29 |
| Summary: | summary |