ENCOMPAS COMFORT BLOCK # 0B-10
FDA 510(k) clearance K933537 · decided 1994-04-08
Clearance details
- K-number
- K933537
- Device name
- ENCOMPAS COMFORT BLOCK # 0B-10
- Applicant
- Encompas Unlimited, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-21
- Decision date
- 1994-04-08
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- MNK
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tierra Verde, FL, 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 |
|---|---|---|
| OXYGEN MOUTHGUARD (K944049) | Endovations, Inc. | 1994-10-11 |
| OXY-BLOC (K931044) | Gi Supply | 1993-10-04 |
| OVERTUBE FOR ENDSCOPIC LIGATOR (K924764) | Superior Healthcare Group, Inc. | 1993-03-15 |
| OXYGUARD (K914978) | Stantex Pty , Ltd. | 1992-01-10 |
| BITE BLOCK (K896691) | Endoscopix | 1990-02-12 |
Recalls involving this device
No recalls on record reference this clearance.