The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Insufflation Needle.
| Device ID | K963359 |
| 510k Number | K963359 |
| Device Name: | INSUFFLATION NEEDLE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Howard V Rowe |
| Correspondent | Howard V Rowe APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-26 |
| Decision Date | 1996-09-24 |
| Summary: | summary |