510(k) K954311
- Device
- KOH COLPOTOMIZER SYSTEM
- Applicant
- COOPERSURGICAL, INC.
- 510(k) number
- K954311
- Product code
- HEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-19
- Date received
- 1995-09-15
- Regulation
- 884.1640
- Classification name
- Culdoscope (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- MARY M MCNAMARA
- Address
- 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers
- 1627186
- 1320468
- 1418479
- 9611102
- 3012783431
- 3009763019
- 3003790304
- 3008693678
- 1519132
- 3007156625
- 2032098
- 1216677
- 2020550
- 8030607
- 3011050570
- 2246552
- 3010202439
- 2528981
- 2027111
- 3009051888
- 3008254127
- 1836161
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases