The following data is part of a premarket notification filed by American Surgical Technologies Corp. with the FDA for 3dscope.
| Device ID | K923160 |
| 510k Number | K923160 |
| Device Name: | 3DSCOPE |
| Classification | Camera, Television, Endoscopic, Without Audio |
| Applicant | AMERICAN SURGICAL TECHNOLOGIES CORP. 88 ESSEX ST. Haverhiill, MA 01832 |
| Contact | P.fallon Iii |
| Correspondent | P.fallon Iii AMERICAN SURGICAL TECHNOLOGIES CORP. 88 ESSEX ST. Haverhiill, MA 01832 |
| Product Code | FWF |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1992-12-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() 3DSCOPE 74392911 not registered Dead/Abandoned |
American Surgical Technologies Corporation 1993-05-19 |
![]() 3DSCOPE 74392910 1822566 Dead/Cancelled |
American Surgical Technologies Corporation 1993-05-19 |
![]() 3DSCOPE 74257253 not registered Dead/Abandoned |
American Surgical Technologies Corporation 1992-03-20 |
![]() 3DSCOPE 74257252 not registered Dead/Abandoned |
American Surgical Technologies Corporation 1992-03-20 |