The following data is part of a premarket notification filed by Naslund Medical Ab with the FDA for Gold Anchor.
Device ID | K091645 |
510k Number | K091645 |
Device Name: | GOLD ANCHOR |
Classification | Accelerator, Linear, Medical |
Applicant | NASLUND MEDICAL AB VASSVAGEN 21 Huddinge, SE 14139 |
Contact | Tomas Naslund |
Correspondent | Tomas Naslund NASLUND MEDICAL AB VASSVAGEN 21 Huddinge, SE 14139 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-04 |
Decision Date | 2009-07-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07340145700216 | K091645 | 000 |
07340145700056 | K091645 | 000 |
07340145700063 | K091645 | 000 |
07340145700087 | K091645 | 000 |
07340145700100 | K091645 | 000 |
07340145700131 | K091645 | 000 |
07340145700155 | K091645 | 000 |
07340145700179 | K091645 | 000 |
07340145700193 | K091645 | 000 |
07340145700032 | K091645 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GOLD ANCHOR 87014127 5174932 Live/Registered |
Camtomsam AB 2016-04-26 |