510(k) K950178
- Device
- PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET
- Applicant
- PHARMA-PLAST INTL. A/S
- 510(k) number
- K950178
- Product code
- LZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-07-17
- Date received
- 1995-01-17
- Regulation
- 888.1520
- Classification name
- Isometer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WALTER PISKORSKI
- Address
- 32 Hemlock St. Londonderry NH US 03053 03053
Source Documents#
Legacy Summary#
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FDA Review#
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