The following data is part of a premarket notification filed by Engineering, Inc. with the FDA for Ls1000 Surgical Aspirator Ii.
Device ID | K854844 |
510k Number | K854844 |
Device Name: | LS1000 SURGICAL ASPIRATOR II |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
Contact | Robert E Lash |
Correspondent | Robert E Lash ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-04 |
Decision Date | 1986-02-12 |