The following data is part of a premarket notification filed by Med-dex Intl. with the FDA for General Purpose Kit.
| Device ID | K881083 |
| 510k Number | K881083 |
| Device Name: | GENERAL PURPOSE KIT |
| Classification | General Surgery Tray |
| Applicant | MED-DEX INTL. SUITE #237 4790 IRVINE BLVD. #105 Irvine, CA 92714 |
| Contact | Diane Momoda-madison |
| Correspondent | Diane Momoda-madison MED-DEX INTL. SUITE #237 4790 IRVINE BLVD. #105 Irvine, CA 92714 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-14 |
| Decision Date | 1988-04-07 |