Btp(Tm) Centraline(Tm) Suit
FDA 510(k) K914615 · Btp Industries, Inc.
510(k) numberK914615
Submission
- Device name
- Btp(Tm) Centraline(Tm) Suit
- Applicant
- Btp Industries, Inc.
S. Hamilton, MA, US - Received
- October 17, 1991
- Decision date
- May 5, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FXO – Suit, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891212 | Aprons, Scrubs Slacks & Tops, Patient DrapeFXO · Traditional | Pro-Safe Professional Linens, Inc. | 04/14/1989SE |
| K882282 | Suit, SurgicalFXO · Traditional | A Plus International, Inc. | 06/23/1988SE |
| K865022 | Surgical GarmentsFXO · Traditional | Ulti-Med Intl., Inc. | 01/12/1987SE |
| K831207 | Spunguard Scrub SuitFXO · Traditional | Kimberly-Clark Corp. | 05/16/1983SE |
| K822483 | Multiple Scrub SuitFXO · Traditional | Surgilite Intl., Inc. | 09/17/1982SE |
Questions and answers
When was Btp(Tm) Centraline(Tm) Suit cleared by the FDA?
Btp(Tm) Centraline(Tm) Suit (K914615) received a 510(k) decision of Substantially Equivalent on May 5, 1992, 201 days after the submission was received.
What is the product code of K914615?
The FDA product code is FXO – Suit, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.