The following data is part of a premarket notification filed by Customed, Inc. with the FDA for O. B. Pack Iv.
| Device ID | K902032 |
| 510k Number | K902032 |
| Device Name: | O. B. PACK IV |
| Classification | Aspirator, Endocervical |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Felix B Santos |
| Correspondent | Felix B Santos CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | HFC |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-04 |
| Decision Date | 1990-09-28 |