The following data is part of a premarket notification filed by Laivan Corp. with the FDA for Total Protective Breatheable Surgical Gowns.
| Device ID | K923815 |
| 510k Number | K923815 |
| Device Name: | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS |
| Classification | Gown, Surgical |
| 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-30 |
| Decision Date | 1993-03-31 |