FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
K Number: K896339
·
Decision Jan 10, 1990
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
15
Review Days
68
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Basic Information
- Device Name
- MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
- K Number
- K896339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Okamoto USA, Inc.
- Date Received
- November 3, 1989
- Decision Date
- January 10, 1990
- Product Code
- HIS
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Okamoto USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252622 | Male Latex Condom HA | May 4, 2026 | Substantially Equivalent |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Feb 18, 2025 | Substantially Equivalent |
| K203541 | Okamoto 002 Lubricated Polyurethane Male Condom | Feb 25, 2022 | Substantially Equivalent |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | Jul 24, 2020 | Substantially Equivalent |
| K141256 | OKAMOTO STUDDED CONDOM | Jul 23, 2014 | Substantially Equivalent |
| K140379 | MEGA BIG BOY CONDOM | Jul 1, 2014 | Substantially Equivalent |
| K090259 | OKAMOTO ULTRA THIN | Mar 31, 2009 | Substantially Equivalent |
| K952393 | OKAMOTO CONDOM | Aug 9, 1995 | Substantially Equivalent |
| K902804 | EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT | Aug 13, 1990 | Substantially Equivalent |
| K884402 | EXTRA STRENGTH SKIN LESS SKIN CONDOM | Mar 10, 1989 | Substantially Equivalent |