The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Polymer Adhesive Bandage.
| Device ID | K883391 |
| 510k Number | K883391 |
| Device Name: | POLYMER ADHESIVE BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | M Mondabaugh |
| Correspondent | M Mondabaugh MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| 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 | 1988-08-09 |
| Decision Date | 1989-03-23 |