The following data is part of a premarket notification filed by Atc Medical Technology, Inc. with the FDA for Modulap.
| Device ID | K982445 |
| 510k Number | K982445 |
| Device Name: | MODULAP |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ATC MEDICAL TECHNOLOGY, INC. 1034 LINCOLN ST. Hollywood, FL 33019 |
| Contact | Marian Harding Cochran |
| Correspondent | Marian Harding Cochran ATC MEDICAL TECHNOLOGY, INC. 1034 LINCOLN ST. Hollywood, FL 33019 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817428020127 | K982445 | 000 |
| 00817428020004 | K982445 | 000 |
| 00817428020011 | K982445 | 000 |
| 00817428020028 | K982445 | 000 |
| 00817428020035 | K982445 | 000 |
| 00817428020042 | K982445 | 000 |
| 00817428020059 | K982445 | 000 |
| 00817428020066 | K982445 | 000 |
| 00817428020073 | K982445 | 000 |
| 00817428020080 | K982445 | 000 |
| 00817428020097 | K982445 | 000 |
| 00817428020103 | K982445 | 000 |
| 00817428020110 | K982445 | 000 |
| 10817428021381 | K982445 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MODULAP 75494836 2264815 Live/Registered |
ATC Technologies, Inc. 1998-06-02 |