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 |