The following data is part of a premarket notification filed by Scott Health Care with the FDA for Hypergel Protective Wound Gel.
| Device ID | K905439 |
| 510k Number | K905439 |
| Device Name: | HYPERGEL PROTECTIVE WOUND GEL |
| Classification | Bandage, Liquid |
| Applicant | SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
| Contact | Richard Hamer |
| Correspondent | Richard Hamer SCOTT HEALTH CARE SCOTT PLAZA III Philadelphia, PA 19113 -1585 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1991-05-29 |