Definition: A Device Intended For Medical Purposes That Consists Of A Strip Of Fabric Material Or Plastic, Coated On One Side With An Adhesive, And May Include A Pad Of Surgical Dressing Without A Disinfectant. The Device Is Used To Cover And Protect Wounds, To
| Device Type ID | 5477 |
| Device Name | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use |
| Physical State | An Adhesive Tape, Bandage, Or Adjustable Closing Mechanism |
| Technical Method | An Adhesive Tape, Bandage, Or Adjustable Closing Mechanism That Is Applied To Minor Cuts And Lacerations |
| Target Area | Use On Superficial Minor Cuts And Lacerations. Excluding Use On Burn Wounds And Deeps Wounds. |
| Regulation Description | Medical Adhesive Tape And Adhesive Bandage. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5240 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PYO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5477 |
| Device | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use |
| Product Code | PYO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Adhesive Tape And Adhesive Bandage. |
| CFR Regulation Number | 880.5240 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ZIPLINE MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |