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 |