BREAST SHELLS
FDA 510(k) clearance K923577 · decided 1993-01-22
Clearance details
- K-number
- K923577
- Device name
- BREAST SHELLS
- Applicant
- Medela, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-20
- Decision date
- 1993-01-22
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- HFS
- Device class
- 1
- Regulation number
- 880.5630
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BREAST SHELL (K944177) | O'Donnell, Byrne & Williams | 1994-10-05 |
| AVENT NIPPLE SHIELD (K944117) | Avent America, Inc. | 1994-10-05 |
| COMFORT PLUS NIPPLE SHIELDS (K935340) | Marshall Baby Products | 1994-01-21 |
| COMFORT PLUS BREAST SHELLS (K935341) | Marshall Baby Products | 1994-01-21 |
| BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS (K930238) | Prolac, Inc. | 1993-08-16 |
| GENTLE FEEL (K864176) | Mali, Inc. | 1986-11-04 |
| UNICARE BREAST SHELLS (K861608) | Unicare Medical Products, Inc. | 1986-07-15 |
| CANNON BABYSAFE NIPPLE SHIELDS (K853176) | Medela, Inc. | 1985-08-22 |
| ARGYLE ENTERNAL FEEDING BAG W/ADMIN (K840877) | Sherwood Medical Co. | 1984-06-28 |
| NUK BREAST SHIELD (K833450) | Reliance Products Corp. | 1983-11-21 |
| AXICARE BREAST SHELL (K811364) | Neonatal Corp. | 1981-08-03 |
Recalls involving this device
No recalls on record reference this clearance.