The following data is part of a premarket notification filed by L H M Ent., Inc. with the FDA for Catheter Care Kits.
| Device ID | K894611 |
| 510k Number | K894611 |
| Device Name: | CATHETER CARE KITS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-12-15 |