FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFT SILICONE ELASTOMER SPONGE EXPLANT
K Number: K780987
·
Decision Sep 28, 1978
Classifications
1
FEI Numbers
77
Registration Numbers
78
Same Product Code
46
Applicant Total
4
Review Days
106
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Basic Information
- Device Name
- SOFT SILICONE ELASTOMER SPONGE EXPLANT
- K Number
- K780987
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4790
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Instrument Research Assoc., Inc.
- Date Received
- June 14, 1978
- Decision Date
- September 28, 1978
- Product Code
- HOZ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOZ | Sponge, Ophthalmic | FDA class 2 | Ophthalmic |
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