FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
OPPORTUNITY INC. GENERAL PURPOSE TRAY
K Number: K971062
·
Decision Jun 9, 1997
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
8
Review Days
77
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Basic Information
- Device Name
- OPPORTUNITY INC. GENERAL PURPOSE TRAY
- K Number
- K971062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Opportunity, Inc.
- Date Received
- March 24, 1997
- Decision Date
- June 9, 1997
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Opportunity, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971088 | OPPORTUNITY INCISION AND DRAINAGE TRAY | Sep 16, 1997 | Substantially Equivalent for Some Indications |
| K971091 | OPPURTUNITY TRACHEOSTOMY CARE KIT | Sep 16, 1997 | Substantially Equivalent for Some Indications |
| K971090 | OPPORTUNITY DRESSING CHANGE TRAY | Sep 16, 1997 | Substantially Equivalent for Some Indications |
| K971093 | OPPORTUNITY I.V. START KIT | Sep 16, 1997 | Substantially Equivalent for Some Indications |
| K971089 | OPPORTUNITY, INC. LACERATION TRAY | Sep 16, 1997 | Substantially Equivalent for Some Indications |
| K971095 | OPPORTUNITY SUTURE REMOVAL KIT | Sep 16, 1997 | Substantially Equivalent for Some Indications |
| K971061 | OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY | Jun 11, 1997 | Substantially Equivalent for Some Indications |