The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Insufflation Tubing.
| Device ID | K924481 |
| 510k Number | K924481 |
| Device Name: | INSUFFLATION TUBING |
| Classification | Insufflator, Laparoscopic |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-03 |
| Decision Date | 1994-03-22 |