FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEXTRA PRECISION POWER SYSTEM
K Number: K853489
·
Decision Sep 30, 1985
Classifications
1
FEI Numbers
387
Registration Numbers
387
Same Product Code
75
Applicant Total
70
Review Days
41
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Basic Information
- Device Name
- DEXTRA PRECISION POWER SYSTEM
- K Number
- K853489
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Chattanooga Group, Inc.
- Date Received
- August 20, 1985
- Decision Date
- September 30, 1985
- Product Code
- HWE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Chattanooga Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Jul 6, 2001 | Substantially Equivalent |
| K982317 | VECTRA COMBO | Feb 1, 1999 | Substantially Equivalent |
| K982324 | VECTRA PRO MODELS 2 AND 4 | Feb 1, 1999 | Substantially Equivalent |
| K982321 | VECTRA STIM MODELS 200 AND 400 | Feb 1, 1999 | Substantially Equivalent |
| K982829 | FORTE, MODEL CPS ULTRASOUND | Nov 6, 1998 | Substantially Equivalent |
| K982828 | FORTE, MODELS CPS 400 STIM, CPS 200 STIM | Nov 6, 1998 | Substantially Equivalent |
| K982830 | FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO | Nov 6, 1998 | Substantially Equivalent |
| K980718 | PARA-CARE | Mar 27, 1998 | Substantially Equivalent |
| K974497 | INTELECT | Jan 23, 1998 | Substantially Equivalent |
| K973024 | INTELECT LEGEND ULTRASOUND | Nov 10, 1997 | Substantially Equivalent |