The following data is part of a premarket notification filed by Laivan Corp. with the FDA for Polyderm Wbc (tm), Waterproof Breathable Cover.
| Device ID | K880206 |
| 510k Number | K880206 |
| Device Name: | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER |
| 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 | 1988-01-15 |
| Decision Date | 1988-03-11 |