FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BASIC, MEDIAN, DOMINANT, AND VARIO
K Number: K983552
·
Decision Jan 7, 1999
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
19
Review Days
90
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Basic Information
- Device Name
- BASIC, MEDIAN, DOMINANT, AND VARIO
- K Number
- K983552
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medela, Inc.
- Date Received
- October 9, 1998
- Decision Date
- January 7, 1999
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medela, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161811 | Medela Low Dose Enteral Syringe | Feb 15, 2017 | Substantially Equivalent |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | Oct 28, 2016 | Substantially Equivalent |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | Jun 6, 2003 | Substantially Equivalent |
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | Mar 7, 2002 | Substantially Equivalent |
| K984589 | PHOTOTHERAPY LAMP | Apr 20, 1999 | Substantially Equivalent |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Dec 12, 1996 | Substantially Equivalent |
| K950750 | MEDELAS BREAST PUMP | Oct 16, 1995 | Substantially Equivalent |
| K952034 | MEDELA'S FOOT PUMP | Sep 12, 1995 | Substantially Equivalent |
| K923577 | BREAST SHELLS | Jan 22, 1993 | Substantially Equivalent |
| K901344 | MEDELA BATTERY OPERATED BREAST PUMP | Aug 6, 1990 | Substantially Equivalent |