The following data is part of a premarket notification filed by I M, Inc. with the FDA for Bandages Catalog Number: 101 To 220.
| Device ID | K871495 |
| 510k Number | K871495 |
| Device Name: | BANDAGES CATALOG NUMBER: 101 TO 220 |
| Classification | Dressing, Wound, Drug |
| Applicant | I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Contact | Amir Porat |
| Correspondent | Amir Porat I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| 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 | 1987-04-16 |
| Decision Date | 1987-05-08 |