The following data is part of a premarket notification filed by Polymint Industrial Co. Ltd. with the FDA for Spyrogel Wound Dressing.
| Device ID | K932457 |
| 510k Number | K932457 |
| Device Name: | SPYROGEL WOUND DRESSING |
| Classification | Tape And Bandage, Adhesive |
| Applicant | POLYMINT INDUSTRIAL CO. LTD. 581 CONFERENCE PLACE Golden, CO 80401 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed POLYMINT INDUSTRIAL CO. LTD. 581 CONFERENCE PLACE Golden, CO 80401 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-21 |
| Decision Date | 1994-02-09 |