The following data is part of a premarket notification filed by Laivan Corp. with the FDA for Modified Labeling For Polyderm Wbc(tm).
| Device ID | K890940 |
| 510k Number | K890940 |
| Device Name: | MODIFIED LABELING FOR POLYDERM WBC(TM) |
| Classification | Dressing, Wound, Drug |
| Applicant | LAIVAN CORP. 49 FRONT ST. P.O. BOX 175 East Rockaway, NY 11518 |
| Contact | Joel Martz |
| Correspondent | Joel Martz LAIVAN CORP. 49 FRONT ST. P.O. BOX 175 East Rockaway, NY 11518 |
| 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 | 1989-02-22 |
| Decision Date | 1989-04-17 |