FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K Number: K003090
·
Decision Oct 18, 2000
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
31
Review Days
15
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Basic Information
- Device Name
- MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
- K Number
- K003090
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Midmark Corp.
- Date Received
- October 3, 2000
- Decision Date
- October 18, 2000
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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|---|---|---|---|
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| K090670 | MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER | Jul 7, 2009 | Substantially Equivalent |
| K023348 | MIDMARK M9 ULTRACLAVE STEAM STERILIZER | Mar 3, 2003 | Substantially Equivalent |
| K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER | Jan 10, 2000 | Substantially Equivalent |
| K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Apr 19, 1999 | Substantially Equivalent |
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Nov 30, 1994 | Substantially Equivalent |
| K926463 | RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES | Oct 21, 1994 | Substantially Equivalent |
| K934744 | MIDMARK MAGNUM GENERAL SURGICAL TABLE | Mar 28, 1994 | Substantially Equivalent |
| K923730 | MODEL 561 C-ARM PROCEDURES STRETCHER | Feb 9, 1994 | Substantially Equivalent |