510(k) K163437
- Device
- Hypodermic Pinpoint™ GT Needle
- Applicant
- C. R. Bard, Inc.
- 510(k) number
- K163437
- Product code
- PVZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-23
- Date received
- 2016-12-07
- Regulation
- 880.5570
- Classification name
- Non-stainless Steel Needle
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jamie Howell
- Address
- 605 N. 5600 W. Salt Lake Ciy, UT US 84116 84116
FDA Registration Numbers#
- 3006082230
- 1018233
- 3006260740
Source Documents#
Legacy Summary#
summary
FDA Review#
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