FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MANAN BONE BIOPSY NEEDLE
K Number: K902177
·
Decision Sep 5, 1990
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
39
Review Days
113
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Basic Information
- Device Name
- MANAN BONE BIOPSY NEEDLE
- K Number
- K902177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Manan Medical Products, Inc.
- Date Received
- May 15, 1990
- Decision Date
- September 5, 1990
- Product Code
- GDM
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Manan Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | Nov 1, 2005 | Substantially Equivalent |
| K011209 | MANAN SPRITACRE SPINAL NEEDLES | Jun 26, 2001 | Substantially Equivalent |
| K983620 | MANAN SPINAL NEEDLES | Jan 8, 1999 | Substantially Equivalent |
| K980536 | EPIDURAL NEEDLE | Jul 31, 1998 | Substantially Equivalent |
| K981386 | MANAN BLUNT NEEDLE | Jun 29, 1998 | Substantially Equivalent |
| K980211 | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES | Feb 6, 1998 | Substantially Equivalent |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | Jan 8, 1998 | Substantially Equivalent |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | Oct 9, 1997 | Substantially Equivalent |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | May 16, 1997 | Substantially Equivalent |
| K961986 | MANAN D BAG | Mar 13, 1997 | Substantially Equivalent |