The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Perval Surgical Gown (marketing Name).
| Device ID | K950504 |
| 510k Number | K950504 |
| Device Name: | PERVAL SURGICAL GOWN (MARKETING NAME) |
| Classification | Gown, Surgical |
| Applicant | STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Contact | Bradley J Bushman |
| Correspondent | Bradley J Bushman STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634916053616 | K950504 | 000 |
| 00634916049176 | K950504 | 000 |
| 00634916041941 | K950504 | 000 |
| 00634916041934 | K950504 | 000 |