The following data is part of a premarket notification filed by Jpi America, Inc. with the FDA for Jpi X-ray Grid.
| Device ID | K945327 |
| 510k Number | K945327 |
| Device Name: | JPI X-RAY GRID |
| Classification | Grid, Radiographic |
| Applicant | JPI AMERICA, INC. 41-02 BELL BLVD. SUITE LL3 Bayside, NY 11361 |
| Contact | Ki M Lee |
| Correspondent | Ki M Lee JPI AMERICA, INC. 41-02 BELL BLVD. SUITE LL3 Bayside, NY 11361 |
| Product Code | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809413810457 | K945327 | 000 |
| 08809413810327 | K945327 | 000 |
| 08809413810310 | K945327 | 000 |
| 08809413810303 | K945327 | 000 |
| 08809413810297 | K945327 | 000 |
| 08809413810280 | K945327 | 000 |
| 08809413810273 | K945327 | 000 |
| 08809413810266 | K945327 | 000 |
| 08809413810211 | K945327 | 000 |
| 08809413810204 | K945327 | 000 |
| 08809413810334 | K945327 | 000 |
| 08809413810341 | K945327 | 000 |
| 08809413810358 | K945327 | 000 |
| 08809413810440 | K945327 | 000 |
| 08809413810433 | K945327 | 000 |
| 08809413810426 | K945327 | 000 |
| 08809413810419 | K945327 | 000 |
| 08809413810402 | K945327 | 000 |
| 08809413810396 | K945327 | 000 |
| 08809413810389 | K945327 | 000 |
| 08809413810372 | K945327 | 000 |
| 08809413810365 | K945327 | 000 |
| 08809413810464 | K945327 | 000 |