FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTECTOR II
K Number: K790661
·
Decision Apr 12, 1979
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
33
Review Days
10
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Basic Information
- Device Name
- PROTECTOR II
- K Number
- K790661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Richard-Allan Medical Ind., Inc.
- Date Received
- April 2, 1979
- Decision Date
- April 12, 1979
- Product Code
- MMK
- 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 |
|---|---|---|---|
| MMK | Container, Sharps | FDA class 2 | General Hospital |
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Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
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Other Clearances by Richard-Allan Medical Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931879 | REFLEX HTR | Mar 24, 1994 | Substantially Equivalent |
| K924200 | REFLEX(R) ESC | Feb 22, 1994 | Substantially Equivalent |
| K926297 | REFLEX ESI | Oct 15, 1993 | Substantially Equivalent |
| K924761 | STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD | Apr 20, 1993 | Substantially Equivalent |
| K900566 | RICHARD-ALLAN VESSEL LOOPS | May 3, 1990 | Substantially Equivalent |
| K896262 | TITANIUM LIGATING CLIPS | Jan 2, 1990 | Substantially Equivalent |
| K890314 | PROTECTOR (SURGICAL INSTRUMENT) | Feb 27, 1989 | Substantially Equivalent |
| K873309 | REFLEX(TM) CA-T CLIP APPLIER | Nov 27, 1987 | Substantially Equivalent |
| K862404 | REFLEX(TM) CLIP APPLIER | Jul 23, 1986 | Substantially Equivalent |
| K862223 | MICRO THIN* PARAFFIN | Jun 17, 1986 | Substantially Equivalent |