The following data is part of a premarket notification filed by Interpro Intl., Inc. with the FDA for Interpro Int'l, Inc. Isolation Gown.
| Device ID | K874766 |
| 510k Number | K874766 |
| Device Name: | INTERPRO INT'L, INC. ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
| Contact | Wayne R Knupp |
| Correspondent | Wayne R Knupp INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-19 |
| Decision Date | 1987-12-10 |