The following data is part of a premarket notification filed by The Hymed Group Corp. with the FDA for Hydrolyzed Collagen/ag Wound Gel With Silver.
| Device ID | K132891 |
| 510k Number | K132891 |
| Device Name: | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER |
| Classification | Dressing, Wound, Drug |
| Applicant | THE HYMED GROUP CORP. 1890 BUCKNELL DR. Bethlehem, PA 18015 |
| Contact | Anita Petito |
| Correspondent | Anita Petito THE HYMED GROUP CORP. 1890 BUCKNELL DR. Bethlehem, PA 18015 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-09-16 |
| Decision Date | 2014-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008336217 | K132891 | 000 |