BTP(TM) CENTRALINE(TM) SUIT
FDA 510(k) clearance K914615 · decided 1992-05-05
Clearance details
- K-number
- K914615
- Device name
- BTP(TM) CENTRALINE(TM) SUIT
- Applicant
- Btp Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-17
- Decision date
- 1992-05-05
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- FXO
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- S. Hamilton, MA, 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 |
|---|---|---|
| APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE (K891212) | Pro-Safe Professional Linens, Inc. | 1989-04-14 |
| SUIT, SURGICAL (K882282) | A Plus International, Inc. | 1988-06-23 |
| SURGICAL GARMENTS (K865022) | Ulti-Med Intl., Inc. | 1987-01-12 |
| SPUNGUARD SCRUB SUIT (K831207) | Kimberly-Clark Corp. | 1983-05-16 |
| MULTIPLE SCRUB SUIT (K822483) | Surgilite Intl., Inc. | 1982-09-17 |
Recalls involving this device
No recalls on record reference this clearance.