510(k) K913848
- Device
- SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR
- Applicant
- SHARPLAN LASERS, INC.
- 510(k) number
- K913848
- Product code
- MGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-27
- Date received
- 1991-08-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- Aspirator, Ultrasonic
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Obstetrics/Gynecology
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUGLASS MEAD
- Address
- 1 Pearl Ct. Allendale NJ US 07401 07401
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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