The following data is part of a premarket notification filed by United Medical Industries Co. Ltd. with the FDA for Unisilk.
Device ID | K042282 |
510k Number | K042282 |
Device Name: | UNISILK |
Classification | Suture, Nonabsorbable, Silk |
Applicant | UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN Riyadh, Central Province, SA 11553 |
Contact | Mohammed Azeez |
Correspondent | Mohammed Azeez UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN Riyadh, Central Province, SA 11553 |
Product Code | GAP |
CFR Regulation Number | 878.5030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-24 |
Decision Date | 2004-12-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06285379148889 | K042282 | 000 |
06285379148872 | K042282 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UNISILK 75122955 2073783 Dead/Cancelled |
LIAO, CAMPBELL C.H. 1996-06-20 |
UNISILK 73337805 not registered Dead/Abandoned |
FLORAL TECH INDUSTRIAL CO., LTD. 1981-11-19 |