Search Results

The Callaly Tampliner is inserted into the vagina and used to absorb menstrual fluid.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the Callaly Tampliner (super plus absorbency). This document is typically issued for medical devices and focuses on substantial equivalence to predicate devices, regulatory compliance, and a brief "Indications for Use" statement.

Crucially, this document DOES NOT contain information regarding device performance studies, acceptance criteria, or any details related to AI/algorithm performance. Therefore, I cannot extract the requested information based on this text.

The document discusses:

• The device name: Callaly Tampliner (super plus absorbency)
• Regulation Number: 21 CFR § 884.5470 (Unscented menstrual tampon)
• Regulatory Class: II
• Product Code: HEB
• Approval for Over-The-Counter Use
• Standard FDA compliance requirements (registration, listing, labeling, GMP, adverse event reporting)

Since the original text does not contain any of the requested information regarding AI/algorithm acceptance criteria or performance studies, I cannot fill out the requested table or answer the specific questions.

Ask a specific question about this device