FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Comatryx OTC
K Number: K232758
·
Decision Dec 1, 2023
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
2
Review Days
84
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Basic Information
- Device Name
- Comatryx OTC
- K Number
- K232758
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Strukmyer Medical, LLC
- Date Received
- September 8, 2023
- Decision Date
- December 1, 2023
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by Strukmyer Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K161311 | USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles | Aug 29, 2016 | Substantially Equivalent |