The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsino Suture Removal Kit.
| Device ID | K050656 |
| 510k Number | K050656 |
| Device Name: | AMSINO SUTURE REMOVAL KIT |
| Classification | Suture Removal Kit |
| Applicant | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DRIVE Pomona, CA 91767 |
| Contact | Ching Ching Seah |
| Correspondent | Ching Ching Seah AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DRIVE Pomona, CA 91767 |
| Product Code | MCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-05-02 |
| Summary: | summary |