The following data is part of a premarket notification filed by Encision, Inc. with the FDA for Disposable Handle Assembles, Models Dh0100 And Dh0500 Series.
| Device ID | K090979 |
| 510k Number | K090979 |
| Device Name: | DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Contact | Judith V King |
| Correspondent | Judith V King ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-05-28 |
| Summary: | summary |