FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SALONMAY BUSTLINE INCREASER
K Number: K770082
·
Decision Mar 16, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
23
Review Days
61
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Basic Information
- Device Name
- SALONMAY BUSTLINE INCREASER
- K Number
- K770082
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Gamma Enterprises, Inc.
- Date Received
- January 14, 1977
- Decision Date
- March 16, 1977
- Product Code
- MWZ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MWZ | Expander, Breast, External | FDA class 1 | Physical Medicine |
Other Clearances by Gamma Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790578 | GAMMA SMAC REAGENTS | May 15, 1979 | Substantially Equivalent |
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | May 3, 1978 | Substantially Equivalent |
| K780506 | CARBON DIOXIDE REAGENTS | May 3, 1978 | Substantially Equivalent |
| K771843 | WETTING AGENTS | Nov 22, 1977 | Substantially Equivalent |
| K771832 | CHLORIDE | Nov 22, 1977 | Substantially Equivalent |
| K771836 | LACTATE DEHYDROGENASE | Nov 22, 1977 | Substantially Equivalent |
| K771834 | CREATININE | Nov 3, 1977 | Substantially Equivalent |
| K771838 | SERUM IRON | Nov 3, 1977 | Substantially Equivalent |