Submission Details
| 510(k) Number | K900642 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 09, 1990 |
| Decision Date | March 19, 1990 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
Cleared
Traditional
SWIVEL ADAPTER
Mar 1990
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K900642 is an FDA 510(k) clearance for the SWIVEL ADAPTER, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Williams Specialty Products, Inc. (Encino, US). The FDA issued a Cleared decision on March 19, 1990, 38 days after receiving the submission on February 9, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.
Device Classification
| Product Code | HHI — System, Abortion, Vacuum |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5070 |
Manufacturer
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