FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMODREN EXCHANGEABLE PLASTIC BELLOWS
K Number: K853295
·
Decision Aug 20, 1985
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
14
Review Days
14
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Basic Information
- Device Name
- EMODREN EXCHANGEABLE PLASTIC BELLOWS
- K Number
- K853295
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- August 6, 1985
- Decision Date
- August 20, 1985
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Parexel Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K900385 | ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE | Jul 9, 1991 | Substantially Equivalent |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | Mar 26, 1991 | Substantially Equivalent |
| K904902 | SMA 26 TRANSDUCER | Mar 26, 1991 | Substantially Equivalent |
| K884800 | ACTA GENOS ELECTROCARDIOGRAPH | Jun 22, 1989 | Substantially Equivalent |
| K862414 | FUJI CR IMAGING PLATE | Feb 26, 1987 | Substantially Equivalent |
| K864519 | PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) | Feb 13, 1987 | Substantially Equivalent |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Jul 1, 1986 | Substantially Equivalent |
| K862416 | FTI 100 MEDICAL THERMAL IMAGER | Jul 1, 1986 | Substantially Equivalent |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Aug 15, 1985 | Substantially Equivalent |
| K851322 | PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH | May 16, 1985 | Substantially Equivalent |