The following data is part of a premarket notification filed by Visualization Technology, Inc. with the FDA for Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,extended Straight Aspirator,13.9 Cm Strag.
| Device ID | K990919 |
| 510k Number | K990919 |
| Device Name: | STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG |
| Classification | System, Image Processing, Radiological |
| Applicant | VISUALIZATION TECHNOLOGY, INC. 200 RESEARCH DR. Wilmington, MA 01887 |
| Contact | Peter Ohanian |
| Correspondent | Peter Ohanian VISUALIZATION TECHNOLOGY, INC. 200 RESEARCH DR. Wilmington, MA 01887 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 1999-04-15 |
| Summary: | summary |