The following data is part of a premarket notification filed by Johnson & Johnson Medical (china) Ltd. with the FDA for Mersilk Black Silk Braided Non-absorbable Suture, Usp.
| Device ID | K012124 |
| 510k Number | K012124 |
| Device Name: | MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | JOHNSON & JOHNSON MEDICAL (CHINA) LTD. #75 NAN GU ZHI ROAD Monhang, Shanghai, CN 200245 |
| Contact | Ben Tang |
| Correspondent | Ben Tang JOHNSON & JOHNSON MEDICAL (CHINA) LTD. #75 NAN GU ZHI ROAD Monhang, Shanghai, CN 200245 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2001-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50749756998852 | K012124 | 000 |