The following data is part of a premarket notification filed by Obp Corporation with the FDA for Anospec Disposable Ansoscope With Light.
| Device ID | K121604 |
| 510k Number | K121604 |
| Device Name: | ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT |
| Classification | Anoscope And Accessories |
| Applicant | OBP CORPORATION 360 MERRIMACK STREET BUILDING 9 Lawrence, MA 01843 |
| Contact | Jason Swift |
| Correspondent | Jason Swift OBP CORPORATION 360 MERRIMACK STREET BUILDING 9 Lawrence, MA 01843 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2012-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M648C0601202 | K121604 | 000 |
| M648C0601102 | K121604 | 000 |
| M648C0601002 | K121604 | 000 |