510(k) K991333
- Device
- MEDI-CULT SPERM FREEZE MEDIUM
- Applicant
- MEDICULT A/S
- 510(k) number
- K991333
- Product code
- MQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-28
- Date received
- 1999-04-19
- Regulation
- 884.6180
- Classification name
- Media, Reproductive
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- RONALD G LEONARDI
- Address
- 9915 Cam, Chirimolla San Diego CA US 92131 92131
FDA Registration Numbers
- 3007800906
- 3004048494
- 3030681110
- 1221433
- 2022379
- 3025773437
- 3014755376
- 3003995932
- 3014295858
- 3021166069
- 3036725842
- 3003766921
- 3008876063
- 2031824
- 3005580113
- 3004882774
- 3003272500
- 3016126174
- 1216677
- 3007738736
- 3017896194
- 3018010054
- 3010413864
- 3033813683
- 3030390242
- 1222779
- 9616005
- 3003274090
- 3012853704
- 3015140190
- 3036495174
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888937028157 | Sperm Freezing Medium | Coopersurgical, Inc. | 2026-02-04 |
| 00888937800678 | Sperm Freezing Medium | Origio A/S | 2016-09-10 |
Legacy Summary
summary
FDA Review
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