The following data is part of a premarket notification filed by L H M Ent., Inc. with the FDA for Single-use, Sterile, Prefilled Syringe, 60cc.
| Device ID | K900439 |
| 510k Number | K900439 |
| Device Name: | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC |
| Classification | Pump, Infusion Or Syringe, Extra-luminal |
| Applicant | L H M ENT., INC. 237 DINGLETOWN RD. Indian Mills, NJ 08088 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb L H M ENT., INC. 237 DINGLETOWN RD. Indian Mills, NJ 08088 |
| Product Code | FIH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-02-15 |