The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Insufflator Tubing With Filter.
| Device ID | K943508 |
| 510k Number | K943508 |
| Device Name: | INSUFFLATOR TUBING WITH FILTER |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Contact | Meg Lannom |
| Correspondent | Meg Lannom Stryker Endoscopy 210 BAYPOINTE PKWY. San Jose, CA 95134 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-20 |
| Decision Date | 1994-11-17 |