FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
10% PVP; 10% PVP IN EBSS SOLUTION
K Number: K011481
·
Decision Jul 2, 2001
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
253
Applicant Total
8
Review Days
49
Basic Information
- Device Name
- 10% PVP; 10% PVP IN EBSS SOLUTION
- K Number
- K011481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CONCEPTION TECHNOLOGIES
- Date Received
- May 14, 2001
- Decision Date
- July 2, 2001
- Product Code
- MQL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by CONCEPTION TECHNOLOGIES
| K Number | Device Name | ||
|---|---|---|---|
| K030850 | ENHANCE HUMAN SERUM ALBUMIN | Apr 8, 2003 | Substantially Equivalent |
| K023717 | SPERM WASH MEDIUM WITH GENTAMICIN | Dec 13, 2002 | Substantially Equivalent |
| K023655 | ENHANCE HTF MEDIUM WITH HEPES | Dec 13, 2002 | Substantially Equivalent |
| K020490 | PBS, PBSW WITH CATIONS AND PHENOL RED | Mar 28, 2002 | Substantially Equivalent |
| K011573 | HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM | Jul 2, 2001 | Substantially Equivalent |
| K011462 | OIL FOR TISSUE CULTURE | Jun 13, 2001 | Substantially Equivalent |
| K993140 | WATER FOR TISSUE CULTURE, MODELS 1500 | Aug 2, 2000 | Substantially Equivalent |