Rochal Bioshield Silicone Film
FDA 510(k) clearance K182733 · decided 2019-06-27
Clearance details
- K-number
- K182733
- Device name
- Rochal Bioshield Silicone Film
- Applicant
- Rochal Industries, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-09-28
- Decision date
- 2019-06-27
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- KMF
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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| MARATHON NO STING LIQUID SKIN PROTECTANT (K133443) | Advanced Medical Solutions (Plymouth), Ltd. | 2014-07-10 |
| LIQUID BANDAGE (K120059) | Chesson Laboratory Associates, Inc. | 2012-05-17 |
| SKIN BARRIER FILM (K092712) | Lodestar Products, Inc. | 2010-02-23 |
| ECOCEL (K083087) | Polichem S.A | 2009-08-07 |
| CHESSON LABS LIQUID BANDAGE (K083913) | Chesson Laboratory Associates, Inc. | 2009-07-31 |
| GLUSEAL 90, MODEL GLU9010 (K083752) | Glustitch, Inc. | 2009-02-23 |
| MRDH BANDAGE (K082703) | Marine Polymer Technologies, Inc. | 2008-10-14 |
Recalls involving this device
No recalls on record reference this clearance.