The following data is part of a premarket notification filed by Laivan Corp. with the FDA for Polyderm A+b(tm).
| Device ID | K880153 |
| 510k Number | K880153 |
| Device Name: | POLYDERM A+B(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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-04-13 |