The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Gown Poly Reinforced Large(product No.900-522)/(reorder No. 0522).
| Device ID | K971920 |
| 510k Number | K971920 |
| Device Name: | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) |
| Classification | Gown, Surgical |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Gladynell Rodriquez |
| Correspondent | Gladynell Rodriquez CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-12-04 |