The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Viscopaste Zinc Paste Bandage.
| Device ID | K863930 |
| 510k Number | K863930 |
| Device Name: | VISCOPASTE ZINC PASTE BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | SMITH & NEPHEW, INC. 1875 HARSH AVE.S.E. P.O.BOX 550 Massillon, OH 44648 -0550 |
| Contact | Gregory, Jr |
| Correspondent | Gregory, Jr SMITH & NEPHEW, INC. 1875 HARSH AVE.S.E. P.O.BOX 550 Massillon, OH 44648 -0550 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-08 |
| Decision Date | 1986-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223415044 | K863930 | 000 |
| 07350041582328 | K863930 | 000 |