The following data is part of a premarket notification filed by Dofi Technologies, Inc. with the FDA for Microendoscope, Miniaturized Biopsy Scope.
| Device ID | K983527 |
| 510k Number | K983527 |
| Device Name: | MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DOFI TECHNOLOGIES, INC. 150 WEST 51ST STREET, #1108 New York, NY 10019 |
| Contact | Tony Anthony |
| Correspondent | Tony Anthony DOFI TECHNOLOGIES, INC. 150 WEST 51ST STREET, #1108 New York, NY 10019 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1999-01-19 |
| Summary: | summary |