FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERI-VAC POWER UNITS
K Number: K781486
·
Decision Sep 27, 1978
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
16
Applicant Total
5
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STERI-VAC POWER UNITS
- K Number
- K781486
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Cpac, Inc.
- Date Received
- August 28, 1978
- Decision Date
- September 27, 1978
- Product Code
- EHZ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EHZ | Evacuator, Oral Cavity | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHZ), ordered by most recent decision date.
IMTEC BONE COLLECTOR SYSTEM
FDA 510(k)
FDA Class 1
·Dental
TAP EXPRESS EJECTOR
FDA 510(k)
FDA Class 1
·Dental
SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
FDA 510(k)
FDA Class 1
·Dental
OROSCOPE MODEL NUMBER COS-100
FDA 510(k)
FDA Class 1
·Dental
DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101
FDA 510(k)
FDA Class 1
·Dental
DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102
FDA 510(k)
FDA Class 1
·Dental