Band-Aid Brand of Adhesive Bandages
FDA 510(k) K770081 · Johnson & Johnson Professionals, Inc.
510(k) numberK770081
Submission
- Device name
- Band-Aid Brand of Adhesive Bandages
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- January 14, 1977
- Decision date
- March 9, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPX – Strip, Adhesive, Closure, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
Other 510(k)s with product code FPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | Medi-Flex Hospital Products, Inc. | 05/09/1997SE |
| K952947 | Delpore Skin ClosureFPX · Traditional | Bitco Intl. | 07/24/1995SE |
| K952702 | Derma SealFPX · Traditional | Ttl Medical | 06/28/1995SE |
| K946321 | Biostrip Sterile Wound Closure StripFPX · Traditional | Cornelia Damsky, Inc. | 01/12/1995SE |
| K931005 | Dukal Skin Closure StripFPX · Traditional | Dukal Corp. | 07/14/1993SE |
| K921775 | Spyroflex Wound ClosuresFPX · Traditional | Polymint Industrial Co. , Ltd. | 05/19/1992SE |
| K894802 | Awc Butterfly Wound ClosuresFPX · Traditional | American White Cross, Inc. | 01/31/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | Tecnol New Jersey Wound Care, Inc. | 07/25/1989SE |
| K874813 | Omed Wound Closure StripsFPX · Traditional | Oxboro Medical Intl., Inc. | 01/29/1988SE |
| K840945 | Skin ClosureFPX · Traditional | Gainor Medical | 10/31/1984SE |
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Questions and answers
When was Band-Aid Brand of Adhesive Bandages cleared by the FDA?
Band-Aid Brand of Adhesive Bandages (K770081) received a 510(k) decision of Substantially Equivalent on March 9, 1977, 54 days after the submission was received.
What is the product code of K770081?
The FDA product code is FPX – Strip, Adhesive, Closure, Skin, a Class I (low risk) device regulated under 21 CFR 880.5240.