The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Endoscopic Access Device.
| Device ID | K960232 |
| 510k Number | K960232 |
| Device Name: | ENDOSCOPIC ACCESS DEVICE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Contact | Kathy Feltrin |
| Correspondent | Kathy Feltrin APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-17 |
| Decision Date | 1996-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071109882 | K960232 | 000 |