The following data is part of a premarket notification filed by Micro-medical Devices, Inc. with the FDA for Access Expansion System.
| Device ID | K951894 |
| 510k Number | K951894 |
| Device Name: | ACCESS EXPANSION SYSTEM |
| Classification | Pneumoperitoneum Needle |
| Applicant | MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Contact | Edwin L Adair |
| Correspondent | Edwin L Adair MICRO-MEDICAL DEVICES, INC. 317 PARAGON WAY Castle Rock, CO 80104 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-06-15 |