FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
K Number: K991757
·
Decision Aug 12, 1999
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
270
Applicant Total
1
Review Days
80
Basic Information
- Device Name
- NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
- K Number
- K991757
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FURLONG INDUSTRIES
- Date Received
- May 24, 1999
- Decision Date
- August 12, 1999
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
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