FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUTODROP 1 AND TUTODROP 2
K Number: K982098
·
Decision Mar 1, 1999
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
259
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Basic Information
- Device Name
- TUTODROP 1 AND TUTODROP 2
- K Number
- K982098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Myco Medical Supplies, Inc.
- Date Received
- June 15, 1998
- Decision Date
- March 1, 1999
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | May 14, 2018 | Substantially Equivalent |
| K090426 | VAKU-8 BLOOD COLLECTION NEEDLES | Jun 12, 2009 | Substantially Equivalent |
| K042504 | CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER | Jan 19, 2006 | Substantially Equivalent |
| K000592 | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET | Apr 12, 2001 | Substantially Equivalent |
| K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | Jun 2, 2000 | Substantially Equivalent |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | Jun 2, 1999 | Substantially Equivalent |
| K990388 | TUTOPLUS IV ADMINISTRATION SET | Mar 29, 1999 | Substantially Equivalent |
| K963364 | GLASS VAN GLASS SYRINGES | May 1, 1998 | Substantially Equivalent |
| K953252 | DISPOSABLE SCALP VEIN INFUSION SET | Nov 26, 1996 | Substantially Equivalent |