The following data is part of a premarket notification filed by L H M Ent., Inc. with the FDA for Irrigation Kit.
| Device ID | K883506 |
| 510k Number | K883506 |
| Device Name: | IRRIGATION KIT |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | L H M ENT., INC. 165 SHEFFIELD CIR. Palm Harbor, FL 33563 |
| Contact | Louis H Mueller |
| Correspondent | Louis H Mueller L H M ENT., INC. 165 SHEFFIELD CIR. Palm Harbor, FL 33563 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-17 |
| Decision Date | 1988-12-13 |