The following data is part of a premarket notification filed by Laivan Corp. with the FDA for Polyderm Pec(tm), Porous Elastic Cover.
| Device ID | K880964 |
| 510k Number | K880964 |
| Device Name: | POLYDERM PEC(TM), POROUS ELASTIC COVER |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-03-17 |