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 |