FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS
K Number: K873097
·
Decision Sep 4, 1987
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
7
Applicant Total
18
Review Days
39
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Basic Information
- Device Name
- PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS
- K Number
- K873097
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ipax, Inc.
- Date Received
- July 27, 1987
- Decision Date
- September 4, 1987
- Product Code
- GBQ
- 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 |
|---|---|---|---|
| GBQ | Catheter, Continuous Irrigation | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Ipax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200893 | ProntoPump Sterile Tube Set | May 4, 2021 | Substantially Equivalent |
| K971242 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | Dec 17, 1997 | Substantially Equivalent |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Jun 20, 1997 | Substantially Equivalent |
| K915158 | SUREBREATH DOME, E-Z BREATHER | Feb 12, 1992 | Substantially Equivalent |
| K915118 | PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE | Dec 27, 1991 | Substantially Equivalent |
| K914172 | KPE 230 AM | Oct 25, 1991 | Substantially Equivalent |
| K914221 | KPE 220 TS, NONSTERILE | Oct 25, 1991 | Substantially Equivalent |
| K884076 | SUREBREATH DOME | Oct 7, 1988 | Substantially Equivalent |
| K870770 | TIMLEINE(TM) VENIPUNCTURE SYSTEM | Apr 23, 1987 | Substantially Equivalent |
| K864726 | I/A/KPE TIP | Jan 20, 1987 | Substantially Equivalent |