The following data is part of a premarket notification filed by Polymint Industrial Co. Ltd. with the FDA for Spyroflex Wound Closures.
| Device ID | K921775 |
| 510k Number | K921775 |
| Device Name: | SPYROFLEX WOUND CLOSURES |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | POLYMINT INDUSTRIAL CO. LTD. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed POLYMINT INDUSTRIAL CO. LTD. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-10 |
| Decision Date | 1992-05-19 |