The following data is part of a premarket notification filed by Saybrex Intl., Inc. with the FDA for Surgical Apparel, Isolation Gown,mask,cap,sleeve.
| Device ID | K884295 |
| 510k Number | K884295 |
| Device Name: | SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE |
| Classification | Chamber, Patient Isolation |
| Applicant | SAYBREX INTL., INC. 215 1/2 SOUTH ARNAZ DR. Beverly Hills, CA 90211 |
| Contact | Joseph Bussel |
| Correspondent | Joseph Bussel SAYBREX INTL., INC. 215 1/2 SOUTH ARNAZ DR. Beverly Hills, CA 90211 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-12 |
| Decision Date | 1988-11-08 |