FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EI DOWNPAK BARRIER SLEEVES
K Number: K073369
·
Decision Feb 27, 2008
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
8
Review Days
89
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Basic Information
- Device Name
- EI DOWNPAK BARRIER SLEEVES
- K Number
- K073369
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hu-Friedy Mfg. Co., Inc.
- Date Received
- November 30, 2007
- Decision Date
- February 27, 2008
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | FDA class 1 | Dental |
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Other Clearances by Hu-Friedy Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | Mar 30, 2010 | Substantially Equivalent |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | Jun 21, 2007 | Substantially Equivalent |
| K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | Feb 1, 2006 | Substantially Equivalent |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | Jul 27, 2001 | Substantially Equivalent |
| K953919 | DENTAL ULTRASONIC SCALER INSERTS | Oct 7, 1995 | Substantially Equivalent |
| K912473 | ACCU-PLACER TM KIT | Jul 24, 1991 | Substantially Equivalent |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | Nov 8, 1984 | Substantially Equivalent |