The following data is part of a premarket notification filed by Accurate Surgical Instruments Co. with the FDA for Catheter Bubble Stand.
Device ID | K813487 |
510k Number | K813487 |
Device Name: | CATHETER BUBBLE STAND |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | ACCURATE SURGICAL INSTRUMENTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-12-01 |
Decision Date | 1981-12-31 |