The following data is part of a premarket notification filed by Aurolab with the FDA for Polycryl.
Device ID | K140039 |
510k Number | K140039 |
Device Name: | POLYCRYL |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | AUROLAB NO 1, SIVAGANGAI MAIN ROAD VEERAPANJAN Madurai, Tamilnadu, IN 625020 |
Contact | Krishna Kumar.r |
Correspondent | Krishna Kumar.r AUROLAB NO 1, SIVAGANGAI MAIN ROAD VEERAPANJAN Madurai, Tamilnadu, IN 625020 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-07 |
Decision Date | 2014-09-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00803878029063 | K140039 | 000 |
00803878029049 | K140039 | 000 |
00803878029025 | K140039 | 000 |
00814106016137 | K140039 | 000 |
00814106016113 | K140039 | 000 |
00814106016090 | K140039 | 000 |
00814106016076 | K140039 | 000 |
10803878041635 | K140039 | 000 |
10803878029039 | K140039 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POLYCRYL 97597034 not registered Live/Pending |
Preservation Solutions, LLC 2022-09-19 |
POLYCRYL 88029442 not registered Live/Pending |
Gardner-Gibson, Inc. 2018-07-09 |
POLYCRYL 85353643 not registered Dead/Abandoned |
Gardner Asphalt Corporation 2011-06-22 |
POLYCRYL 73672719 1492231 Dead/Cancelled |
POLYTECH INCORPORATED 1987-07-17 |
POLYCRYL 73506861 1390416 Live/Registered |
MORTON THIOKOL, INC. 1984-11-02 |
POLYCRYL 73134286 1092793 Dead/Cancelled |
T. S. Simms & Co. Limited 1977-07-18 |
POLYCRYL 72179881 0777075 Dead/Expired |
FARAH MANUFACTURING COMPANY, INC. 1963-10-28 |