The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Isolate Adhesive Bandage For Moist Wound.
| Device ID | K843139 |
| 510k Number | K843139 |
| Device Name: | ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND |
| Classification | Dressing, Wound, Drug |
| Applicant | CHESEBROUGH-POND'S U.S.A. CO. TRUMBULL INDUSTRIAL PARK Trumbull, CT 06611 |
| Contact | De Graad |
| Correspondent | De Graad CHESEBROUGH-POND'S U.S.A. CO. TRUMBULL INDUSTRIAL PARK Trumbull, CT 06611 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-09 |
| Decision Date | 1984-11-08 |