The following data is part of a premarket notification filed by Advanced Medical Components, Inc. with the FDA for Needle Syringe Disposal Device.
| Device ID | K896195 |
| 510k Number | K896195 |
| Device Name: | NEEDLE SYRINGE DISPOSAL DEVICE |
| Classification | Container, Sharps |
| Applicant | ADVANCED MEDICAL COMPONENTS, INC. P.O. BOX 10064 Lansing, MI 48901 |
| Contact | Lynn Niles |
| Correspondent | Lynn Niles ADVANCED MEDICAL COMPONENTS, INC. P.O. BOX 10064 Lansing, MI 48901 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-25 |
| Decision Date | 1989-11-27 |