The following data is part of a premarket notification filed by J.j. Skinner, Inc. with the FDA for Jj Skinner Carekits Wound Care Management/dressing Change Tray.
| Device ID | K961227 |
| 510k Number | K961227 |
| Device Name: | JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY |
| Classification | Wrap, Sterilization |
| Applicant | J.J. SKINNER, INC. STARKS BUILDING, SUITE 825 455 S. 4TH. AVE. Louisville, KY 40202 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula J.J. SKINNER, INC. STARKS BUILDING, SUITE 825 455 S. 4TH. AVE. Louisville, KY 40202 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-28 |
| Decision Date | 1996-06-10 |
| Summary: | summary |