510(k) K895164
- Device
- EAGLE DS
- Applicant
- AMERICAN STERILIZER CO.
- 510(k) number
- K895164
- Product code
- ECG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-17
- Date received
- 1989-08-22
- Regulation
- 872.6710
- Classification name
- Sterilizer, Boiling Water
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL ZMUDA
- Address
- 2424 W. 23rd St. P.O. Box 620 Erie PA US 16514 16514
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ECG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843234 | CITOMAT AUTOCLAVES | Lic-Orthion | 1984-10-25 |
| K811237 | MAGNETIC RETENTION UNIT | Universiti Malaya | 1981-06-16 |
| K810977 | ENDODONTIC POST SYSTEMS | Preat Corp. | 1981-05-13 |
| K790290 | NEY EQUI-HINGE | Deringer-Ney, Inc. | 1979-04-10 |
| K790078 | BAR & RIDER, SCREWS, TUBES | Eurodent, Inc. | 1979-02-27 |
| K771266 | STEAM STERILIZER | Amsco Hospital Products Co. | 1977-08-02 |
Legacy Summary#
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FDA Review#
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